K-Pack II KN-2516RB04Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05413206003808), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2021Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE K-PACK II WAS USED INTRA-OPERATIVE. THE NEEDLE BECAME STUCK INSIDE THE PATIENT'S THIGH. THE PHYSICIAN REALIZED AFTER INJECTING THE VACCINE THAT THE CANNULA OF THE NEEDLE HAD DISAPPEARED. HE THOUGHT IT HAD FALLEN; HOWEVER, AS HE COULD NOT FIND IT, HE SENT THE CHILD FOR A THIGH X-RAY, WHICH CONFIRMED THAT THE CANNULA WAS STUCK INSIDE. THE CHILD MUST UNDERGO A SURGERY. THE VACCINE, PRIORIX, WAS ADMINISTERED.
Patient problems: Foreign Body In Patient
MAUDE report 11131715 ↗
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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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