Port Access Needle 011901NYRecalls & reported problems
Bard Access Systems, Inc. · HuberPlus 19G x 1" with Y-Site and Needleless Injection Site · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741065484), received between Jul 18, 2019 and Jan 8, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Collapse” (1 report).
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
- Collapse1
- Failure to Infuse1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2021Collapse
ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE, LUNG CANCER AND CORONARY OBSTRUCTION PULMONARY DISEASE. WHILE RECEIVING OUTPATIENT CHEMOTHERAPY, IT WAS ATTEMPTED TO ACCESS PATIENT PORT. WHEN THE PORT KIT WAS OPENED, NEEDLE WAS COLLAPSED WITH NO SHEATH COVERING NEEDLE. THE NEEDLE WAS UNABLE TO BE USED. NO KNOWN HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11138924 ↗MalfunctionJul 18, 2019Failure to Infuse; Physical Resistance/Sticking
IT WAS REPORTED THAT NURSE OPENED THIS SET OF HUBER NEEDLE AND STARTED TO PRIME THE HUBER NEEDLE WITH 10CC HEPARIN SALINE. SHE FELT RESISTANCE OF INFUSING HUBER NEEDLE FROM THE LUER LOCK SYRINGE AND HUBER TUBE WAS NOT CLAMPED. SHE INFUSED SLIGHTLY HARDER AND FOUND THAT ONLY A FEW DROPS OF HEPARIN SALINE WERE OUT FROM HUBER NEEDLE. SHE STOPPED INFUSING AND INFORMED HER NURSE MANAGER IMMEDIATELY. NURSE MANGER INSTRUCTED THE NURSE TO OPEN A NEW BOX OF HUBER NEEDLE FOR THIS PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8804107 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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