SPROTTE® 131151-30C (UDI 04048223130049)Recalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 22G x 43/4" (120mm),sterile, with Introducer 1,00 x 40mm · Class 2
All models of SPROTTE (32)
Data updated Oct 16, 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 04048223130049), received between Jul 21, 2026 and Jul 21, 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. 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
- 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 21, 2026Break
IRN# (B)(4) THIS INCIDENT TOOK PLACE IN FRANCE. THE DEPARTMENT REPORTED AN INITIAL FAILURE OF THE LUMBAR PUNCTURE PROCEDURE USING A STANDARD INTRODUCER. THE LUMBAR. PUNCTURE WAS SUBSEQUENTLY PERFORMED USING A LONG ATRAUMATIC NEEDLE. DURING NEEDLE ADVANCEMENT, BONY CONTACT. OCCURRED. UPON WITHDRAWAL, THE NEEDLE FRACTURED AT ITS MIDPOINT, LEAVING A FRAGMENT IN SITU. THE PATIENT WAS TRANSFERRED TO THE NEURORADIOLOGY DEPARTMENT, WHERE AN INCISION WAS MADE TO REMOVE THE NEEDLE FRAGMENT UNDER FLUOROSCOPIC GUIDANCE. THE LUMBAR PUNCTURE WAS THEN SUCCESSFULLY COMPLETED UNDER FLUOROSCOPIC GUIDANCE. PAIN AT THE PUNCTURE SITE WAS REPORTED FOLLOWING THE PROCEDURE AND WAS RELIEVED BY THE ADMINISTRATION OF 1 G OF PARACETAMOL. NO OTHER COMPLICATIONS HAVE BEEN OBSERVED TO DATE. THE BROKEN NEEDLE FRAGMENT WAS SUCCESSFULLY REMOVED UNDER FLUOROSCOPIC GUIDANCE.
Patient problems: Foreign Body In Patient
MAUDE report 25885073 ↗
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
- ARROW IPN922632Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 recalls0 reports
- ARROW IPN922603Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922604Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- 22G 1 1/2IN Regional Block Needle 408348Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922605Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- BD QUINCKE Spinal Needles 405180Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)23 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page