SPROTTE® 021251-30ARecalls & reported problems
Pajunk GmbH Medizintechnologie · Needle · Class 2
Data updated Oct 13, 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 04048223114865), received between Jul 15, 2026 and Jul 15, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
InjuryJul 15, 2026Break
IRN# (B)(4). THIS INCIDENT TOOK PLACE IN FRANCE. 23-YEAR-OLD PATIENT HOSPITALIZED FOR INVESTIGATION OF INTRACRANIAL HYPERTENSION. AN ATTEMPT AT LUMBAR PUNCTURE WAS MADE ON (B)(6) 2026 WITH PREMEDICATION USING 20 MG OF SERESTA AND APPLICATION OF AN EMLA PATCH APPROXIMATELY 30 MINUTES BEFORE THE PROCEDURE. SKIN PREPARATION WAS PERFORMED WITH SOAP FOLLOWED BY CHLORHEXIDINE. A 24G VIOLET NEEDLE WAS USED. DESPITE A PROPERLY CONDUCTED PROCEDURE, IT WAS IMPOSSIBLE TO REACH THE VERTEBRAE (BMI: 39.96). THE NEEDLE WAS INSERTED ALMOST UP TO THE HUB, AND WITHDRAWAL OF THE STYLET PROVED DIFFICULT; IT WAS EVENTUALLY REMOVED, TWISTED AT ITS TIP. REMOVAL OF THE NEEDLE SHOWED THAT IT WAS SPLIT IN ITS DISTAL THIRD. A LUMBAR SPINE X-RAY WAS PERFORMED, CONFIRMING THAT A 6.62 MM FRAGMENT OF THE NEEDLE REMAINED AT THE LEVEL OF THE L4-L5 INTERSPINOUS SPACE. REMOVAL OF THE NEEDLE FRAGMENT WAS CARRIED OUT UNDER GENERAL ANESTHESIA BY A NEUROSURGEON ON (B)(6) 2026.
Patient problems: Foreign Body In Patient
MAUDE report 25824574 ↗
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
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- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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