Port Access Needle SHW19-75YRecalls & reported problems
Bard Access Systems, Inc. · (EXP) POWERLOC EZ 19GA X 0.75in · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741089763), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THIS PORT WAS CANNULATED AND USED YESTERDAY WITH NO DOCUMENTED ISSUES. WHEN MY TRIAGE NURSE WENT TO FLUSH IT TODAY TO GET BLOOD SAMPLES, SHE WAS HAVING TROUBLE FLUSHING AND NOTICED THE SALINE WAS DRIPPING OUT OF THE CATHETER INSTEAD OF ADVANCING FORWARD. THE LEAK OCCURRED AT THE HARD PLASTIC PART NEAR THE Y-SITE BEFORE YOU GET THE PART OF THE LINE WHERE WE ATTACH THE MICROCLAVE. SHE DECANNULATED THE PORT AND THEN THIS VIDEO WAS TAKEN TO FURTHER DEMONSTRATE THE BREAK" ADDITIONAL INFO REC'D 09/02/2020: "WAS THERE PATIENT HARM REPORTED?: NO". "WHAT THEY¿RE BEING TREATED FOR: COLORECTAL CANCER". "CONCOMITANT THERAPY: FOLFOX CHEMOTHERAPY".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10547808 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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