Ponsky PEG Safety SystemRecalls & reported problems across all models

We found 3 models of Ponsky PEG Safety System by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2017 and Jun 5, 2023 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ponsky PEG Safety System problems

Ponsky PEG Safety System models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ponsky PEG Safety System 006035

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  32 reports
• Ponsky PEG Safety System 003029

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  2 reports
• Ponsky PEG Safety System 003027

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  1 report

Recent Ponsky PEG Safety System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST FEEDING DEVICE PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED INFECTION AT THE STOMA SITE. HOWEVER, THERE IS NO INFORMATION REGARDING ADDITIONAL INTERVENTION OR MEDICATION PROVIDED TO TREAT INFECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057970 ↗
• MalfunctionFeb 16, 2022Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST FEEDING DEVICE PLACEMENT PROCEDURE, THE INTERNAL BUMPER OF THE DEVICE ALLEGEDLY DETACHED AND THE TUBE CAME OFF WHEN THE DEVICE WAS TRIED TO BE USED, THE INTERNAL BUMPER WAS REPORTED TO HAVE BEEN EXCRETED WITH THE STOOL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539955 ↗
• MalfunctionNov 1, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SIX MONTHS POST DEVICE IMPLANT, THE INTERNAL BUMPER WAS ALLEGEDLY BROKEN AND WAS FOUND TO BE INSIDE THE STOMACH. IT WAS FURTHER REPORTED THAT THE BUMPER WAS REMOVED USING AN ENDOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726032 ↗
• MalfunctionSep 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST DEVICE PLACEMENT, THE FEEDING ADAPTER OF THE TUBE ALLEGEDLY CAME OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493713 ↗
• MalfunctionAug 31, 2021Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST CATHETER IMPLANT, THE FEEDING ADAPTER ALLEGEDLY HAD DIFFICULTY CONNECTING WITH THE ENTERAL NUTRITION. THE DEVICE WAS REPORTED TO BE EXPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390247 ↗
• MalfunctionJul 30, 2021Loss of or Failure to Bond; Fracture; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Fracture; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE APPROXIMATELY SEVEN MONTHS POST FEEDING DEVICE IMPLANT, THE INTERNAL BUMPER ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE INTERNAL BUMPER WAS REMOVED USING AN ENDOSCOPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253338 ↗
• MalfunctionJun 7, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE DEVICE REMOVAL PROCEDURE, THE DEVICE WAS ALLEGEDLY BROKEN AND REMAINED IN THE STOMACH. IT WAS FURTHER REPORTED PART WAS REMOVED USING AN ENDOSCOPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945014 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE FEEDING TUBE PLACEMENT PROCEDURE, THE TRANSVERSE COLON WAS ALLEGEDLY PERFORATED AND RESULTING IN TRANSVERSE COLON FISTULA. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bowel Perforation; Fistula

  MAUDE report 11918983 ↗
• MalfunctionMar 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT DURING EXCHANGING THE CATHETER, THE BUMPER ALLEGEDLY CAME OFF. IT WAS FURTHER REPORTED THAT THE BUMPER LEFT IN THE PATIENT BODY WAS REMOVED USING ENDOSCOPE. THE HEALTH INJURY TO THE PATIENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559287 ↗
• MalfunctionDec 24, 2020Fracture; Malposition of Device; Fracture; Malposition of Device

  IT WAS REPORTED THAT APPROXIMATELY 34 DAYS POST FEEDING TUBE PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND PENETRATED TRANSVERSE COLON. IT WAS FURTHER REPORTED THAT DEVICE WAS USED MULTIPLE TIMES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11070916 ↗
• MalfunctionDec 1, 2020Peeled/Delaminated; Deformation Due to Compressive Stress; Peeled/Delaminated; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A FEEDING DEVICE PLACEMENT PROCEDURE, THE SURFACE OF THE WIRE WAS ALLEGEDLY FOUND PEELED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926749 ↗
• MalfunctionNov 26, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE UPON OPENING THE PORT DEVICE PACKAGE, THE FORCEPS WAS ALLEGEDLY MISSING IN THE KIT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910778 ↗
• MalfunctionNov 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT POST IMPLANTED PROCEDURE APPROXIMATELY, THE DEVICE ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED ON PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10827394 ↗
• MalfunctionNov 2, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT TWENTY-FOUR DAYS POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE DEPTH MARKINGS ALLEGEDLY DISAPPEARED ON THE TUBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10770719 ↗
• MalfunctionOct 26, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST FEEDING TUBE PLACEMENT, THE LINEAR EXTERNAL BOLSTER ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734370 ↗

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