Port Access Needle S02022-75Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 22G x 0.75 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 00801741048869), received between Apr 4, 2019 and Nov 1, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Contamination /Decontamination Problem1
- Defective Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient2
- 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.
MalfunctionNov 1, 2019Defective Component; Defective Component
IT WAS REPORTED THAT THE NEEDLE BENT WHEN INSERTED. SAFETY MECHANISM SLIPS OUT WHEN INSERTED AND THIS CAUSED LEAKAGE. GRIP TO HOLD THE NEEDLE VERY SMALL AND WHEN HOLDING THE WINGS THE NEEDLE SLIPS BACK INTO THE SAFETY CAP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9266440 ↗MalfunctionOct 24, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material
IT WAS REPORTED BY PATIENT THAT AFTER TAKING OFF THE NEEDLE CAP, A PIECE OF BLUE FOAM OR GAUZE WAS NOTICED ON THE TIP OF THE NEEDLE. NEEDLE WAS NOT USED OR INSERTED INTO PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9234526 ↗MalfunctionApr 4, 2019Break
IT WAS REPORTED THAT THE SECURITY LOCK WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8483086 ↗
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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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