Port Access Needle 012034Recalls & reported problems
Bard Access Systems, Inc. · HuberPlus 20G x .75" · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741065620), received between Nov 2, 2018 and Jun 16, 2022 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (4 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 16, 2026.
Most reported problems
Device problems
- Activation Problem4
- Crack4
- Fluid/Blood Leak2
- Material Integrity Problem2
- Problem with Sterilization2
- Contamination /Decontamination Problem1
- Packaging Problem1
- Separation Problem1
Patient problems
- No Known Impact Or Consequence To Patient9
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Burn, Thermal1
- Needle Stick/Puncture1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2022Activation Problem; Activation Problem
IT WAS REPORTED "THE NEEDLE CANT RETRACTED." PATIENT STATUS/ INTERVENTION: CHANGE NEW NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14714353 ↗MalfunctionDec 15, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT PATIENTS WHO USE THIS PRODUCT FOR CANCER DRUG INFUSION HAVE LEAKAGE AT THE JOINT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13013848 ↗MalfunctionAug 26, 2021Activation Problem; Activation Problem
IT WAS REPORTED THAT THE PATIENT HAS FINISHED THE TREATMENT AND THE NURSE REMOVES THE NEEDLE. WHEN IT IS DISCARDED, THE SAFETY VALVE BOUNCES, CAUSING THE NURSE TO STICK THE NEEDLE. PATIENT HAVE COMPLETED THE TREATMENT. FACILITY PERFORM BLOOD DATAS ABOUT HEPATITIS B, HIV AND SYPHILIS FOLLOW UP. BOTH OF PATIENT AND NURSE ARE CURRENTLY NEGATIVE.
Patient problems: Needle Stick/Puncture
MAUDE report 12373832 ↗MalfunctionMay 6, 2021Activation Problem; Activation Problem
IT WAS REPORTED THAT "CAN¿T ACTIVE SAFETY MECHANISM. REMOVE WITH UNSAFETY WAY." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11783290 ↗MalfunctionSep 24, 2020Activation Problem; Activation Problem
IT WAS REPORTED THAT DURING REMOVAL, THE SAFETY MECHANISM COULD NOT BE ACTIVATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10583721 ↗MalfunctionMar 12, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE CONNECTION SITE BETWEEN HUB AND SET WAS FOUND TO BE LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9823571 ↗MalfunctionJan 3, 2019Separation Problem
IT WAS REPORTED THAT THE CONNECTION SITE SEPARATED DURING THE 1ST FLUSH. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8215366 ↗MalfunctionDec 21, 2018Crack
IT WAS REPORTED THAT WHEN ATTEMPTING TO ATTACH THE NEEDLELESS CONNECTOR TO THE END OF THE TUBING, THE TUBING/CONNECTION WAS CRACKED. IT IS STATED THAT NO FORCE WAS USED TO TIGHTEN THE CONNECTION. IT WAS REPORTED THAT THIS HAPPENED TWO TIMES ON THE SAME PATIENT REQUIRING REACCESS. THIS REPORT ADDRESSES THE SECOND DEVICE USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8189521 ↗MalfunctionDec 21, 2018Crack
IT WAS REPORTED THAT WHEN ATTEMPTING TO ATTACH THE NEEDLELESS CONNECTOR TO THE END OF THE TUBING, THE TUBING/CONNECTION WAS CRACKED. IT IS STATED THAT NO FORCE WAS USED TO TIGHTEN THE CONNECTION. IT WAS REPORTED THAT THIS HAPPENED TWO TIMES ON THE SAME PATIENT REQUIRING REACCESS. THIS REPORT ADDRESSES THE FIRST DEVICE USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8189497 ↗InjuryDec 21, 2018Crack
IT WAS REPORTED THAT WHEN ATTEMPTING TO ATTACH THE NEEDLELESS CONNECTOR TO THE END OF THE TUBING, THE TUBING/CONNECTION WAS CRACKED. IT IS STATED THAT NO FORCE WAS USED TO TIGHTEN THE CONNECTION. ADDITIONAL INFORMATION RECEIVED STATED: "THE PATIENT'S SKIN WAS BURNED."
Patient problems: Burn, Thermal
MAUDE report 8189493 ↗MalfunctionNov 2, 2018Problem with Sterilization
IT WAS REPORTED THAT THE PACKAGING HAD WARPED, CAUSING THE PAPER SEAL TO LIFT, RESULTING IN COMPROMISING THE STERILITY OF THE PRODUCT. THE ISSUE WAS REPORTED ON 6 DEVICES OF THE SAME BATCH CODE. THIS REPORT ADDRESSES THE FIFTH NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8034638 ↗MalfunctionNov 2, 2018Problem with Sterilization
IT WAS REPORTED THAT THE PACKAGING HAD WARPED, CAUSING THE PAPER SEAL TO LIFT, RESULTING IN COMPROMISING THE STERILITY OF THE PRODUCT. THE ISSUE WAS REPORTED ON 6 DEVICES OF THE SAME BATCH CODE. THIS REPORT ADDRESSES THE SIXTH NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8034630 ↗MalfunctionNov 2, 2018Material Integrity Problem
IT WAS REPORTED THAT THE PACKAGING HAD WARPED, CAUSING THE PAPER SEAL TO LIFT, RESULTING IN COMPROMISING THE STERILITY OF THE PRODUCT. THE ISSUE WAS REPORTED ON 6 DEVICES OF THE SAME BATCH CODE. THIS REPORT ADDRESSES THE FOURTH NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8034535 ↗MalfunctionNov 2, 2018Material Integrity Problem
IT WAS REPORTED THAT THE PACKAGING HAD WARPED, CAUSING THE PAPER SEAL TO LIFT, RESULTING IN COMPROMISING THE STERILITY OF THE PRODUCT. THE ISSUE WAS REPORTED ON 6 DEVICES OF THE SAME BATCH CODE. THIS REPORT ADDRESSES THE SECOND NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8034045 ↗MalfunctionNov 2, 2018Contamination /Decontamination Problem
IT WAS REPORTED THAT THE PACKAGING HAD WARPED, CAUSING THE PAPER SEAL TO LIFT, RESULTING IN COMPROMISING THE STERILITY OF THE PRODUCT. THE ISSUE WAS REPORTED ON 6 DEVICES OF THE SAME BATCH CODE. THIS REPORT ADDRESSES THE THIRD NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8034043 ↗MalfunctionNov 2, 2018Packaging Problem
IT WAS REPORTED THAT THE PACKAGING HAD WARPED, CAUSING THE PAPER SEAL TO LIFT, RESULTING IN COMPROMISING THE STERILITY OF THE PRODUCT. THE ISSUE WAS REPORTED ON 6 DEVICES OF THE SAME BATCH CODE. THIS REPORT ADDRESSES THE FIRST NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8033944 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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