K-Pack II KN-2525RB04Recalls & reported problems
Terumo Europe NV · K-Pack II Needle · Class 2
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 05413206032648), received between Apr 24, 2019 and Apr 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE THAT THE INVOLVED K-PACK CANNULA WAS DETACHED FROM THE HUB OF THE NEEDLE DURING USE. THE PATIENT WAS NOT HARMED; NO INFORMATION WAS REPORTED ABOUT PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 4, 2019. THE NEEDLE WAS USED WITH A SLIP TIP SYRINGE. THE VACCINE WAS BOOSTRIX. THE TYPE OF DAMAGE WAS DETACHMENT WITHOUT BREAKAGE OR CUTTING OF THE CANNULA. THE INJECTION WAS ALREADY PERFORMED; BEFORE THE REPORTED EVENT OCCURRED, THE CANNULA DETACHED AFTER COMPLETE ADMINISTRATION OF THE VACCINE. IT WAS REPORTED THAT THE USER DID NOT HAVE THE INFORMATION IN REGARDS TO WHETHER THE CANNULA DETACHED WHILE BEING IN THE PATIENT OR OUTSIDE OF THE PATIENT. IT IS UNKNOWN HOW THE CANNULA WAS REMOVED FROM THE PATIENT; IF IT WAS DETACHED IN THE PATIENT.
Patient problems: No Information
MAUDE report 8544620 ↗
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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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