Port Access Needle 0632015Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 20G x 1.5 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741047558), received between Apr 24, 2018 and Jul 2, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Device Contamination with Chemical or Other Material1
- Device Reprocessing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, LEAKING NEEDLE. THERE WAS NO HARM OR IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383128 ↗MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT NEEDLE WAS LEAKING DURING SALINIZATION OF CATHETER. NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22322195 ↗MalfunctionApr 24, 2018Device Reprocessing Problem; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN THE DEVICE WAS RECEIVED, THE PRODUCT WAS DIRTY INSIDE THE BOX. THE DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7456241 ↗
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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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