Port Access Needle 583112Recalls & reported problems
Bard Access Systems, Inc. · Sfty Huber 22Ga x .75in · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741044885), received between May 23, 2018 and Jun 4, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak4
- Crack1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CUSTOMER HAD LEAKING OF HUBER NEEDLE WHILE ADMINISTERING ADRIAMYCIN. CALLED END CUSTOMER, WHO EXPLAINED THE LEAKED WAS NOTED WHILE ADMINISTERING THE CHEMO DRUG. THERE WAS SOME LEAKING ON TO PATIENT'S SKIN, NURSE WAS WEARING PPE. CUSTOMER REPORTS THE LEAK WAS IN THE TUBING OUTSIDE OF THE DRESSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10121489 ↗MalfunctionJul 24, 2018Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSE FOUND THE DEVICE LEAKING FROM THE CONNECTION OF THE TUBING AND THE BASE PLATE WHEN SHE ATTEMPTED TO FLUSH WITH SALINE SYRINGE PRIOR TO INFUSION. THE NURSE REPORTED THAT THIS HAPPENED TWO TIMES IN THE SAME PATIENT. THIS REPORT ADDRESSES THE SECOND EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7716057 ↗MalfunctionJul 24, 2018Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSE FOUND THE DEVICE LEAKING FROM THE CONNECTION OF THE TUBING AND THE BASE PLATE WHEN SHE ATTEMPTED TO FLUSH WITH SALINE SYRINGE PRIOR TO INFUSION. THE NURSE REPORTED THAT THIS HAPPENED TWO TIMES IN THE SAME PATIENT. THIS REPORT ADDRESSES THE FIRST EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7716042 ↗MalfunctionMay 23, 2018Crack; Fluid/Blood Leak
DURING THE EVALUATION OF THE SAMPLE THE ENGINEER DISCOVERED THAT THE RETURNED SAMPLE EXHIBITED CRACKS IN THE NEEDLE HOUSING WHICH RESULTED IN A LEAK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7539206 ↗
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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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