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Dual Port Feeding Adaptor 000333Recalls & reported problems

Bard Access Systems, Inc. · Dual Port Feeding Adaptor · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Bard Dual Port Feeding Adaptor is a connector used with gastrointestinal feeding tubes. The 25 reports that name its identifier describe leaks, loose caps and fittings, and parts breaking or coming apart, with no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
25
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10801741080934), received between May 4, 2017 and Jun 7, 2022 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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, 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

Device problems

  • Fluid/Blood Leak7
  • Fitting Problem5
  • Detachment of Device or Device Component4
  • Loose or Intermittent Connection4
  • Defective Component2
  • Deformation Due to Compressive Stress2
  • Fracture2
  • Leak/Splash2

Patient problems

  • No Consequences Or Impact To Patient13
  • No Clinical Signs, Symptoms or Conditions8
  • No Known Impact Or Consequence To Patient4
  • No Information1

Recent adverse event reports

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

  • MalfunctionJun 7, 2022Fracture; Material Separation; Deformation Due to Compressive Stress; Fracture; Material Separation; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT APPROXIMATELY FOUR OR FIVE YEARS POST FEEDING TUBE PLACEMENT PROCEDURE, THE SILICON BUTTON ALLEGEDLY DEGRADED. IT WAS FURTHER REPORTED THAT BUTTON ALLEGEDLY BREAK. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14617192 ↗
  • MalfunctionJun 7, 2022Fracture; Material Separation; Deformation Due to Compressive Stress; Fracture; Material Separation; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT APPROXIMATELY FOUR OR FIVE YEARS POST FEEDING TUBE PLACEMENT PROCEDURE, THE SILICON BUTTON ALLEGEDLY DEGRADED. IT WAS FURTHER REPORTED THAT THE BUTTON ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14614077 ↗
  • MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT POST DEVICE IMPLANT, THE DEVICE WAS ALLEGEDLY LEAKING AT THE FEEDING PORT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12298977 ↗
  • MalfunctionAug 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE TIP OF THE DEVICE ALLEGEDLY HAD AN EXTERNAL LEAK. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12266773 ↗
  • MalfunctionJun 23, 2021Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

    IT WAS REPORTED THAT SOMETIME POST PORT DEVICE IMPLANT, THE DEVICE WAS ALLEGEDLY LEAKING. IT WAS FURTHER REPORTED THAT THE FOOD PARTICLES WERE CLOGGING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12047667 ↗
  • MalfunctionMay 21, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAP WAS ALLEGEDLY BECAME LOOSE AND QUICKLY CAME OFF AND GOT WET. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11863273 ↗
  • MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT SOME TIME POST PLACEMENT PROCEDURE, THE CAP ON THE FEEDING ADAPTER BECAME LOOSE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11804306 ↗
  • MalfunctionFeb 1, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

    IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD FLUID LEAK. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11257562 ↗
  • MalfunctionOct 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT POST FEEDING DEVICE IMPLANT, THE ADAPTER OF THE DEVICE ALLEGEDLY WAS LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10612704 ↗
  • MalfunctionSep 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD A LEAK IMMEDIATELY AFTER THE FIRST USE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10552574 ↗
  • MalfunctionFeb 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT, THE ADAPTER ON THE FEEDING TUBE ALLEGEDLY LEAKED. REPORTEDLY, THE ADAPTER IS SCHEDULED TO BE REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9708829 ↗
  • MalfunctionMay 13, 2019Fitting Problem; Fitting Problem

    IT WAS REPORTED DURING EVALUATION OF THE RETURNED SAMPLE, THE PRIMARY PORT WAS ALLEGEDLY FOUND TO BE OUT OF SPECIFICATION. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8604254 ↗
  • MalfunctionOct 25, 2018Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT THE Y-PORT ALLEGEDLY WOULD NOT STAY CONNECTED TO THE PEG TUBING. IT WAS FURTHER REPORTED THAT DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8007671 ↗
  • MalfunctionAug 29, 2018Fitting Problem; Defective Component; Fitting Problem; Defective Component

    IT WAS REPORTED THAT THE LARGE CAP ON THE DUAL PORT FEEDING ADAPTER BECAME LOOSE ONE MONTH AFTER PLACEMENT AND CAP WAS EASILY REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7830846 ↗
  • MalfunctionAug 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT AFTER APPROXIMATELY ONE WEEK, THE CAP ON THE DEVICE BROKE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7782401 ↗
  • MalfunctionAug 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE CAP ON THE FEEDING ADAPTER ALLEGED BROKE ONCE WEEK AFTER PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7767917 ↗
  • MalfunctionAug 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE CAP ON THE FEEDING ADAPTER ALLEGED BROKE ONCE WEEK AFTER PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7767901 ↗
  • MalfunctionJul 23, 2018Fitting Problem; Fitting Problem

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

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

    MAUDE report 7712239 ↗
  • MalfunctionJul 23, 2018Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT EVERY TIME THE DEVICE IS USED THE CAP (SMALL) COMES OF EASILY. TAPE WAS USED TO SECURE THE CAP. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7712229 ↗
  • MalfunctionJul 23, 2018Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE BASE OF THE CAP (LARGE) WAS BROKEN SEVERAL DAYS AFTER PLACEMENT. THE DEVICE WAS TAPED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7712226 ↗
  • MalfunctionJul 11, 2018Defective Component; Defective Component

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE ATTACHED SECURELY TO THE GASTROSTOMY CATHETER CAUSING LEAK. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7680086 ↗
  • MalfunctionMay 9, 2018Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE FEEDING ADAPTOR WAS DAMAGED AND A LEAK WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7500732 ↗
  • MalfunctionAug 9, 2017Loose or Intermittent Connection

    IT WAS REPORTED THAT WHEN REPLACING THE FEEDING ADAPTER WITH A NEW ONE, THE NEW FEEDING ADAPTER COULD NO BE CONNECTED TO THE CATHETER DUE TO THE LOOSENESS OF THE CONNECTING PART.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6778511 ↗
  • MalfunctionAug 1, 2017Difficult to Open or Close

    IT WAS REPORTED THAT, JUST AFTER PLACEMENT, THE SAFETY CAP OF THE MAIN PORT WOULD NOT CLOSE. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6759035 ↗
  • MalfunctionMay 4, 2017Leak/Splash; Loose or Intermittent Connection

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF LOOSE CAP AND LEAKAGE FROM THE ADAPTOR. THE HEALTH PROFESSIONAL CONFIRMED THAT THE CAP OF ADAPTOR WAS LOOSE. THE ADAPTOR HAD BEEN USED SINCE (B)(6) 2017. NO REPORTED PATIENT HARM.

    Patient problems: No Information

    MAUDE report 6546170 ↗

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Sources and updates

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