Port Access Needle 2205222Recalls & reported problems
Bard Access Systems, Inc. · Winged Infusion Set 22G x 0.75 inch with y-site · Class 2
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741065873), received between Jun 1, 2018 and Oct 27, 2022 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak8
- Break7
- Detachment of Device or Device Component2
- Leak/Splash1
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THE NURSE FOUND THE CURVE OF THE NEEDLE HAS A LEAK. IT WAS IMMEDIATELY CHANGED. NO PATIENT INJURY REPORTED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15682018 ↗MalfunctionOct 27, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THE NURSE FOUND THE CURVE OF THE NEEDLE HAS A LEAK. IT WAS IMMEDIATELY CHANGED. NO PATIENT INJURY REPORTED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15681837 ↗MalfunctionMay 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT "THE NEEDLE EXTENSION OF THE PORTA-CATH IS LEAKING, LETTING AIR IN THE WHOLE SET. HENCE, CREATING BUBBLES. AND SINCE THIS IS A CENTRAL LINE DEVICE EQUIPMENT IT IS CRITICAL THAT AIR IS NOT IN THE PICTURE. OTHERWISE, WE ARE PUTTING THE PATIENT AT RISK FOR MULTIPLE COMPLICATIONS. IT WAS REMOVED AS SOON AS STAFF NOTICED THAT THERE ARE BUBBLES AND TRIED AGAIN. WE ARE USING IT MOSTLY FOR PEDIATRIC PATIENTS AND YOU KNOW HOW PEDIATRICS CAN GET VERY IRRITATED/UNCOMFORTABLE DURING THE PROCEDURE THE SECOND TIME AROUND DUE TO FAULTY DEVICE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14518722 ↗MalfunctionMay 26, 2022Material Deformation; Material Deformation
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "ONCE WE FLUSHED THE SYSTEM, THE CAP THAT WAS COVERING THE PIGGYBACK SITE FLEW INTO THE AIR." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14518693 ↗MalfunctionJan 26, 2022Break; Break
IT WAS REPORTED, "WE HAD THREE INCIDENTS IN PEDIATRIC WARD WHERE THE TUBING DISCONNECTED FROM THE HUB WITH THE BELOW HIGHLIGHTED PRODUCT. UNFORTUNATELY THIS IS EXTREMELY UNSAFE GIVEN THERE IS A BREACH IN THE INTEGRITY OF CENTRAL VENOUS DEVICES AND ALSO IT IS BEING USED AS A CONNECTOR BETWEEN THE IV FLUID BAG AND HUBER NEEDLE IN ONCOLOGY CHILDREN." THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13359469 ↗MalfunctionJan 26, 2022Break; Break
IT WAS REPORTED, "WE HAD THREE INCIDENTS IN PEDIATRIC WARD WHERE THE TUBING DISCONNECTED FROM THE HUB WITH THE BELOW HIGHLIGHTED PRODUCT. UNFORTUNATELY THIS IS EXTREMELY UNSAFE GIVEN THERE IS A BREACH IN THE INTEGRITY OF CENTRAL VENOUS DEVICES AND ALSO IT IS BEING USED AS A CONNECTOR BETWEEN THE IV FLUID BAG AND HUBER NEEDLE IN ONCOLOGY CHILDREN." THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13359467 ↗MalfunctionJan 26, 2022Break; Break
IT WAS REPORTED, "WE HAD THREE INCIDENTS IN PEDIATRIC WARD WHERE THE TUBING DISCONNECTED FROM THE HUB WITH THE BELOW HIGHLIGHTED PRODUCT. UNFORTUNATELY THIS IS EXTREMELY UNSAFE GIVEN THERE IS A BREACH IN THE INTEGRITY OF CENTRAL VENOUS DEVICES AND ALSO IT IS BEING USED AS A CONNECTOR BETWEEN THE IV FLUID BAG AND HUBER NEEDLE IN ONCOLOGY CHILDREN." THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13359464 ↗MalfunctionDec 19, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED DISCONNECTION BETWEEN Y-PORT AND THE SECONDARY INJECTION TUBE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9496589 ↗MalfunctionDec 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE MEDICATION LEAKED ON THE CONNECTION PART BETWEEN Y-PORT AND THE SECONDARY INJECTION TUBE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9496322 ↗MalfunctionOct 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE LINE IS DETACHED FROM THE END OF THE WING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9234970 ↗MalfunctionOct 16, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THE LINE IS DETACHED FROM THE END OF THE WING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9199884 ↗MalfunctionOct 14, 2019Break; Break
IT WAS REPORTED "THE NEEDLE EXTENSION WAS CUT FROM THE LUER LOCK SIDE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9188761 ↗MalfunctionAug 21, 2019Break; Material Split, Cut or Torn; Break
IT WAS REPORTED "THE NEEDLE EXTENSION WAS CUT FROM THE LUER LOCK SIDE".
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8918866 ↗MalfunctionMar 28, 2019Fluid/Blood Leak
IT WAS REPORTED THAT WHEN SALINE SOLUTION WAS INFUSED INTO THE DEVICE BEFORE USE, LEAKAGE WAS FOUND FROM THE TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8461645 ↗MalfunctionJun 1, 2018Leak/Splash
IT WAS REPORTED THAT WHILE INFUSING A HIGH CONCENTRATION VITAMIN THROUGH THE DEVICE, LEAKAGE WAS CONFIRMED FROM THE CONNECTION PART OF THE DEVICE AND THE ADMINISTRATION SET. NO PATIENT HARM REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7561109 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.