Safety Needle 7527942002Recalls & reported problems
Steripack Medical Poland Sp Z O O · Class 2
- 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 05907527942002), received between Dec 9, 2016 and Dec 9, 2016 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Disconnection1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2016Break; Disconnection
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY NEEDLE. CUSTOMER REPORTS: THE NURSE NOTICED THAT THE NEEDLE WAS BROKEN (BLUE NEEDLE HUB) BEFORE INJECTION. THE HUB ASSEMBLY AND NEEDLE DISCONNECTED FROM THE SYRINGE. THERE WAS NO HARM TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6159727 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.