SPROTTE® NRFit 051163-29ARecalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® NRFit · Class 2
All models of SPROTTE NRFit (7)
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 14048223026981), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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
- Device Misassembled During Manufacturing /Shipping1
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.
MalfunctionJan 27, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IRN# (B)(4). NRFIT PACKET CONTAINED A NON NRFIT SPINAL NEEDLE. ANAESTHETIST WAS UNABLE TO ADMINISTER BLOCK WITHOUT REMOVING AND CHANGING THE SPINAL NEEDLE. NARRATIVE FROM THE CER: THE HOSPITAL HAVE CONVERTED TO NRFIT. THEY USE NRFIT SPROTTE. THEY OPENED A BOX OF NRFIT SPROTTE NEEDLESIN THEATRES, OPENED THE PACKET, TOOK THE NEEDLE OUT, INSERTED IT INTO THE PATIENT, AND FOUND THE NRFIT SYRINGE WOULDNT CONNECT. ON CLOSER INSPECTION, THEY FOUND THIS NEEDLE TO BE A LUER SPROTTE. STAFF THEN OPENED ANOTHER BOX AND FOUND 1 X MORE UNIT OF A LUER SPROTTE, IN A NRFIT SPROTTE BOX. HENCE THE 2 X LOT NUMBERS. THEATRE STAFF ON SITE DISPOSED OF THE NEEDLES INTO THE SHARPS BIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11234658 ↗
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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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