Bard Tri-Funnel Replacement Gastrostomy TubeRecalls & reported problems across all models

We found 7 models of Bard Tri-Funnel Replacement Gastrostomy Tube by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 342 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2016 and Aug 22, 2022 — classified as 1 death, 14 injuries, 327 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (104 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 Bard Tri-Funnel Replacement Gastrostomy Tube problems

Bard Tri-Funnel Replacement Gastrostomy Tube models

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

• Bard Tri-Funnel Replacement Gastrostomy Tube 000720

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  1 death170 reports
• Bard Tri-Funnel Replacement Gastrostomy Tube 000724

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  53 reports
• Bard Tri-Funnel Replacement Gastrostomy Tube 000718

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  37 reports
• Bard Tri-Funnel Replacement Gastrostomy Tube 000716

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  29 reports
• Bard Tri-Funnel Replacement Gastrostomy Tube 000714

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  26 reports
• Bard Tri-Funnel Replacement Gastrostomy Tube 000722

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  16 reports
• Bard Tri-Funnel Replacement Gastrostomy Tube 000712

  TUBES, GASTROINTESTINAL (AND ACCESSORIES)
  11 reports

Recent Bard Tri-Funnel Replacement Gastrostomy Tube adverse event reports

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

• MalfunctionAug 22, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE BALLOON WAS ALLEGEDLY BROKEN AT THE MOMENT OF INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264016 ↗
• MalfunctionApr 11, 2022Break; Fluid/Blood Leak; Migration; Break; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT NEXT DAY POST FEEDING TUBE PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY CAME OUT AND HAD LEAK ISSUE. IT WAS FURTHER REPORTED THAT THE CUFF ALLEGEDLY FOUND TO BE RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14071242 ↗
• MalfunctionFeb 11, 2022Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO A GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A LEAK AND THE BALLOON WAS NOT INFLATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13511738 ↗
• MalfunctionDec 7, 2021Fluid/Blood Leak; Fracture; Inflation Problem; Fluid/Blood Leak; Fracture; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO A GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE WAS PREPPED BY INFUSING WATER INTO THE BALLOON TRACK AND THE WATER ALLEGEDLY LEAKED THROUGH THE END HOLE AND THE DEVICE DID NOT INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958253 ↗
• MalfunctionDec 7, 2021Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO A GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE WAS PREPPED BY INFUSING WATER INTO THE BALLOON TRACK AND THE WATER ALLEGEDLY LEAKED THROUGH THE END HOLE AND THE DEVICE DID NOT INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958252 ↗
• MalfunctionOct 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629903 ↗
• MalfunctionOct 10, 2021Degraded; Fluid/Blood Leak; Migration; Degraded; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST TUBE PLACEMENT, THE TUBE ALLEGEDLY BUSTED AND COMPLETELY DESTROYED AND WHAT LITTLE WAS LEFT WAS BLACK IN COLOR. IT WAS FURTHER REPORTED THAT ACID LEAKING AROUND THE BALLOON. REPORTEDLY, THE BALLOON SLIDES IN AND OUT FREELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Skin Inflammation/ Irritation

  MAUDE report 12602653 ↗
• InjuryOct 10, 2021Burst Container or Vessel; Degraded; Material Discolored; Fluid/Blood Leak; Migration; Burst Container or Vessel; Degraded; Material Discolored; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST FEEDING TUBE PLACEMENT, THE TUBE ALLEGEDLY HAD A BURST AND COMPLETELY DESTROYED AND WHAT LITTLE WAS LEFT WAS BLACK IN COLOR. IT WAS FURTHER REPORTED THAT ACID WAS ALLEGEDLY LEAKING AROUND THE BALLOON AND IRRITATING THE TRACT WITH PAIN. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 12602652 ↗
• InjurySep 29, 2021Fracture; Device Dislodged or Dislocated; Migration; Fracture; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY DISLODGED AND FELL OUT OF THE PATIENT. THE PATIENT WAS REPORTEDLY STABILIZED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12548466 ↗
• MalfunctionSep 9, 2021Fracture; Device Dislodged or Dislocated; Migration; Fracture; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY DISLODGED AND FELL OUT OF THE PATIENT. THE PATIENT WAS REPORTEDLY STABILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446789 ↗
• InjuryAug 11, 2021Inflation Problem; Defective Component; Inflation Problem; Defective Component

  IT WAS REPORTED THAT DURING GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD DEFECTIVE COMPONENT AND INFLATION PROBLEM. THE PROCEDURE WAS COMPLETED BY A SURGICAL INTERVENTION. THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12306350 ↗
• MalfunctionJul 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE CAP WAS ALLEGEDLY TEARED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236947 ↗
• MalfunctionJul 28, 2021Disconnection; Fracture; Device Dislodged or Dislocated; Disconnection; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SOMETIMES POST FEEDING DEVICE PLACEMENT, THE PROBE ALLEGEDLY DISLODGED. IT WAS FURTHER REPORTED THAT THE CUFF ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236909 ↗
• MalfunctionJul 23, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT AFTER PLACING THE GASTROSTOMY TUBE, IT WAS NOTICED THAT THERE WAS NO PRINTING ON THE GASTROSTOMY TUBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215781 ↗
• InjuryJul 16, 2021Burst Container or Vessel; Disconnection; Fluid/Blood Leak; Fracture; Device Dislodged or Dislocated; Burst Container or Vessel; Disconnection; Fluid/Blood Leak; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TEN DAYS POST DEVICE PLACEMENT, THE FEEDING TUBE ALLEGEDLY CAME OUT OF THE DEVICE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RUPTURED AND EXTRAVASATION WAS NOTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN

  Patient problems: Extravasation

  MAUDE report 12178985 ↗

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