Ponsky Non-Balloon Replacement (NBR) Gastrostomy Tube 000702Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741036293), received between Apr 28, 2016 and Dec 22, 2022 — classified as 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT POST GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE CONNECTION OF THE CAP WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16031420 ↗
• MalfunctionJul 28, 2021Contamination /Decontamination Problem; Difficult to Open or Close; Contamination /Decontamination Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE FEEDING DEVICE PLACEMENT PROCEDURE, THE LID OF THE FEEDING ADAPTER COULD NOT BE CLOSED AND ALLEGEDLY THERE WAS A FOREIGN MATERIAL AT THE LID. THEREFORE, UPON THE REMOVAL OF FOREIGN MATERIAL, THE LID WAS ABLE TO BE CLOSED AND PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236908 ↗
• MalfunctionSep 1, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, UPON UNPACKING THE FEEDING DEVICE KIT, THE OBTURATOR WAS ALLEGEDLY FOUND MISSING IN THE KIT PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10475551 ↗
• MalfunctionApr 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY FEEDING TUBE PLACEMENT, AN ALLEGED LEAK WAS IDENTIFIED FROM THE CAP OF THE FEEDING ADAPTER. REPORTEDLY, FEEDING ADAPTER WAS REMOVED AND ANOTHER FEEDING ADAPTER WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9981303 ↗
• MalfunctionNov 5, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT UPON OPENING THE FEEDING DEVICE KIT, THE OBTURATOR COMPONENT WAS ALLEGEDLY MISSING. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9279814 ↗
• MalfunctionJul 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000702, FEEDING DEVICE ALLEGEDLY EXPERIENCED FOREIGN MATERIAL PRESENT IN THE DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796607 ↗
• MalfunctionApr 19, 2019Component Missing; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THIS EVENT INDICATED THAT MODEL 702 FEEDING DEVICE EXPERIENCED A MISSING COMPONENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THERE WAS NO PATIENT INVOLVEMENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8533222 ↗
• MalfunctionApr 19, 2019Material Perforation; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THIS EVENT INDICATED THAT MODEL 000702 FEEDING DEVICE EXPERIENCED MATERIAL PERFORATION. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THERE WAS ONE PATIENT INVOLVED WITH NO PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532541 ↗
• MalfunctionApr 19, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THIS EVENT INDICATED THAT MODEL 000702 FEEDING DEVICE EXPERIENCED A DEFECTIVE COMPONENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THERE WAS ONE PATIENT INVOLVED WITH NO PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532469 ↗
• MalfunctionOct 24, 2018Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS ATTACHED TO THE CAP, AT THE TIP OF THE OBTURATOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001868 ↗
• MalfunctionOct 23, 2018Fitting Problem; Defective Component; Fitting Problem; Defective Component

  IT WAS REPORTED THAT THE CAP ON THE DUAL PORT FEEDING ADAPTER DID NOT CLOSE WELL AND STUCK TIGHT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7997307 ↗
• MalfunctionAug 14, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT DAMAGE AT THE DISTAL END OF THE OBTURATOR WAS FOUND AT THE TIME OF OPENING THE PACKAGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7782267 ↗
• MalfunctionJul 31, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE SMALL CAP OF THE DEVICE WILL OPEN WHEN THE CATHETER IS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737008 ↗
• MalfunctionJul 25, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CAP OF THE LARGE PORT OF THE FEEDING ADAPTER BECAME LOOSE A FEW DAYS AFTER PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7718770 ↗
• MalfunctionJul 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NUTRITION LEAKED OUT FROM THE FISTULA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7679950 ↗
• InjuryOct 12, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE INTERNAL DOME FELL INTO THE PATIENT'S STOMACH. THE DOME WAS RETRIEVED WITH A SNARE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6944668 ↗
• MalfunctionOct 11, 2017Component Falling

  IT WAS REPORTED THAT THE INTERNAL DOME FELL INTO PATIENT¿S SMALL INTESTINE WHEN EXCHANGING THE CATHETER ON (B)(6) 2017. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE INTERNAL DOME SOON AND WAIT UNTIL THE DOME IS NATURALLY DISCHARGED FROM THE PATIENT BODY. THE DOME WAS DISCHARGED ON (B)(6) 2017. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6942509 ↗
• MalfunctionOct 5, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT 4 DAYS AFTER THE PLACEMENT, THE DEVICE WAS EXTRACTED SPONTANEOUSLY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917784 ↗
• MalfunctionOct 5, 2017Break

  IT WAS REPORTED THAT WHEN INSERTING THE CATHETER INTO THE PATIENT, THE INTERNAL DOME WAS BROKEN THROUGH BY THE OBTURATOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917608 ↗
• MalfunctionOct 3, 2017Break

  IT WAS REPORTED THAT ONE WEEK AFTER PLACEMENT, THE CAP OF ADAPTOR WAS BROKEN, SO THE OPERATOR CEASED USING THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6909526 ↗
• MalfunctionSep 28, 2017Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LEAKAGE OF THE STOMACH CONTENTS FROM THE LOOSE ADAPTOR CAP OF THE DEVICE WAS OBSERVED.

  Patient problems: No Information

  MAUDE report 6902269 ↗
• MalfunctionSep 28, 2017Break

  IT WAS REPORTED THAT THE FEEDING ADAPTER WAS DAMAGED IN LESS THAN 4 MONTHS AFTER STARTING TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901749 ↗
• MalfunctionAug 31, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BLACK STAIN WAS FOUND IN THE CATHETER LUMEN. ALTHOUGH THE CATHETER WAS WASHED BY RUBBING WITH A BRUSH, THE STAIN WAS NOT REMOVED. DURING PLACEMENT, THE USED MEDICINES WERE AS FOLLOWED; LANSOPRAZOLE, FUROSEMIDE, CLARITHROMYCIN, SPIRONOLACTONE, ITOPRIDE, CARBOCISTEINE, RHUBARB, LIQUORICES ROOT, SODIUM CHLORIDE, NAUZELIN DRY SYRUP, AND PANTETHINE ACID. ON (B)(6) 2017-EVALUATION NOTED STAIN HAS APPEARANCE OF MOLD. CONSERVATIVELY REPORTED.

  Patient problems: No Information

  MAUDE report 6836601 ↗
• MalfunctionAug 9, 2017Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CAP OF FEEDING PORT COULD NOT BE CLOSED TIGHTLY, AND THE LEAKAGE WAS OBSERVED FROM THERE. THE LEAKAGE HAD CONTINUED SINCE THE PLACEMENT OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6778586 ↗
• MalfunctionAug 3, 2017Reflux within Device; Difficult to Open or Close

  IT WAS REPORTED THAT THE CAP OF THE SIDE PORT WOULD NOT CLOSE AND THAT A LITTLE FRACTION OF THE SOLUTION INJECTED INTO THE STOMACH WOULD REFLUX THROUGH THE SIDE PORT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6765688 ↗