Port Access Needle 0632210Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 22G x 1 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 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 00801741047589), received between Apr 5, 2019 and May 3, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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.
Most reported problems
Device problems
- Obstruction of Flow2
- Malposition of Device1
Patient problems
- Discomfort2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2019Obstruction of Flow; Malposition of Device
IT WAS REPORTED VIA MEDWATCH "INFANT PEDIATRIC PATIENT ACCESS WITH A PORT-A-CATH (PAC) NEEDLE. IV PUMP ALARMING DOWNSTREAM OCCLUSION THROUGHOUT THE SHIFT. THE PAC SAFETY NEEDLE WAS RETRACTING OUT OF THE PORT, REQUIRING REINFORCEMENT OF THE NEEDLE UNDERNEATH THE DRESSING. THIS WAS CAUSING STRESS AND PAIN FOR THE PATIENT."
Patient problems: Discomfort; Pain
MAUDE report 8579286 ↗MalfunctionApr 5, 2019Obstruction of Flow
INFANT PEDIATRIC PATIENT ACCESSED WITH A PORT-A-CATH (PAC) NEEDLE. IV PUMP ALARMING DOWNSTREAM OCCLUSION THROUGHOUT THE SHIFT. THE PAC SAFETY NEEDLE WAS RETRACTING OUT OF PORT, REQUIRING REINFORCEMENT OF THE NEEDLE UNDERNEATH THE DRESSING. THIS WAS CAUSING STRESS AND PAIN FOR THE PATIENT.
Patient problems: Discomfort; Pain
MAUDE report 8486275 ↗
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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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