K-Pack II KN-2713RBRecalls & reported problems
Terumo Europe NV · K-Pack II Needle · Class 2
Data updated Oct 16, 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 05413206020546), received between Oct 4, 2023 and Oct 4, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Suction Problem” (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.
Reports received per month
Most reported problems
Device problems
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2023Suction Problem; Suction Problem
THE USER FACILITY REPORTED THAT THE INVOLVED K-PACK II NEEDLES AFFECTS CO-PACKED WITH MIRCERA. A PHARMACIST IN THE RENAL UNIT HAD A PATIENT THAT WAS ADMINISTERED THEIR MIRCERA THROUGH A PORT. THE PORT IS CONNECTED TO A DIALYSIS MACHINE (PER CMI THROUGH THE HEMODIALYSIS VASCULAR ACCESS). THE MIRCERA TWO COMPONENTS (NEEDLE + PRE-FILLED SYRINGE) WAS ATTACHED TOGETHER, THEN THE NEEDLE SHIELD WAS TAKEN OFF. THE NEEDLE WAS THEN INJECTED INTO THE PORT, NEXT THE INJECTED WAS THE DRUG HOWEVER WHEN THE DRUG WAS PRESSED DOWN THROUGH THE PORT THE NEEDLE WAS SUCKED INTO THE MACHINE AND WAS CAUGHT BY THE FILTER. THE TEAM WAS ABLE TO RETRIEVE THE NEEDLE. THE MIRCERA 100 MCG PRE-FILLED SYRINGE PATIENT WAS HOOKED TO THE MACHINE. THE PATIENT DID RECEIVE THEIR DOSE. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENTS' FINAL IMPACT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17874046 ↗
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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 13, 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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