Port Access Needle 0681910Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 19G x 1 inch with y-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 00801741047985), received between May 25, 2023 and Jun 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Component Missing2
- Incomplete or Missing Packaging1
- No Fail-Safe Mechanism1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2023Component Missing; Component Missing
IT WAS REPORTED BY THE CUSTOMER PORT NEEDLE EXPOSED IN PACKAGING. NEEDLE MISSING PROTECTIVE COVER WHEN PACKAGE OPENED. NO ONE PUNCTURED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17121386 ↗MalfunctionMay 25, 2023Component Missing; Incomplete or Missing Packaging; No Fail-Safe Mechanism
BARD PORT NEEDLE EXPOSED IN PACKAGING. NEEDLE MISSING PROTECTIVE COVER WHEN PACKAGE OPENED. NO ONE PUNCTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001585 ↗
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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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