Percutaneous endoscopic gastrostomy (PEG) tubes are commonly placed to provide long-term enteral nutrition to patients suffering with neurological dysphagia and head and neck cancers. It is safe and effective when performed by experts; however, device-related problems and patient-related adverse events are known but underreported. We aimed to analyse device-related problems and patient-related adverse events associated with PEG tubes reported in the Manufacturer and User Facility Device Experience (MAUDE) database.

MAUDE database of the USFDA was accessed (URL link: video abstract). A total of 2,032 reports were collected between December 2008 and August 2025 using the search terms “PEG tube,” “Gastrostomy tube,” and “Percutaneous endoscopic gastrostomy tube.” All reports were exported to Microsoft excel sheet, duplicates were carefully sorted out and data was analysed for device-related problems and patient-related adverse events using the software inbuilt in Excel.

A total of 2185 device-related problems and 897 patient-related adverse events were reported in the MAUDE database from a total of 2032 individual reports with highest number of events reported in 2024 (n=291, 14.32%). More than one device-related problem was identified in 334 (16.44 %) reports. The most common device-related problems reported were leaks/splashes (n = 254, 11.62%), breakage (n = 237, 10.85%), and detachment of the device or device component (n = 224, 10.25%) (Figure 1).

There was no impact on the patient and/or no known consequence in majority of the cases (n = 1162, 57.18%). However, the most frequent patient related complications reported were foreign body in the patient (n = 90, 10.03%), infection (n = 68, 7.58%), pain (n = 47, 5.24%), feeding problems (n = 34, 3.79%), device embedded in tissue/plaque (n = 19, 2.12%), implant failure (n = 19, 2.12%), and hemorrhage/bleeding (n = 18, 2.01%). Mortality was mentioned as an event type “death” in 0.98% (n = 20) of the patient-related events (Figure 2)

Table 1 - Most common device-related problems reported for PEG tubes in the FDA MAUDE database,  (N = 2185)

Device-related problems n (%)Leak/Splash 254 (11.62 %)Break 237 (10.85 %)Detachment of Device or Device Component 224 (10.25 %)Obstruction of Flow 135 (6.18 %)Device Dislodged or Dislocated 121 (5.54 %)Burst Container or Vessel 66 (3.02 %)Fracture 58 (2.12 %)Fluid/Blood Leak 58 (2.65 %)Material Rupture 55 (2.52 %)Device Contamination with Chemical or Other Material 49 (2.24%)

Table 2 - Most common patient-related adverse events reported in association with PEG tubes in the FDA MAUDE database,  (N = 897)

Patient-related adverse events n (%)Foreign Body in Patient 90 (10.03 %)Infection 68 (7.58%)Pain 47 (5.24%)Feeding problem 34 (3.79%)Device embedded in tissue/plaque 19 (2.12%)Failure of implant 19 (2.12%)Hemorrhage/bleeding 18 (2.01%)Peritonitis 18 (2.01%)Bowel perforation 18 (2.01%)Vomiting 18 (2.01%)

PEG tube placement is safe and effective. Patient-related incidents were uncommon and rarely fatal. Tube leaks/splashes and breaks were the most common device-related problems. Continuous innovation and improvement are required to reduce the number of device-related issues and improve patient safety.