SPROTTE® 121151-30A (UDI 04048223107119)Recalls & reported problems
Pajunk GmbH Medizintechnologie · Distal Tip: SPROTTE® Proximal End: ISO 80369-7 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223107119), received between Jan 19, 2022 and Jul 8, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN THE UK. PROBLEM WITH THE NEEDLE, WHEREBY THE FIRST 4.5 CM OF THE NEEDLE TIP BROKE (POTENTIALLY OFF THE INTRODUCER, WHILST CAUGHT ON THE TRANSVERSE PROCESS' VERTEBRAE. THE PATIENT HAS A VERY HIGH BMI.
Patient problems: Foreign Body In Patient
MAUDE report 22436795 ↗MalfunctionJan 19, 2022Break; Break
IRN# (B)(4). INITIAL REPORTER´S NARRATIVE/ INFORMATION PROVIDED IN INITIAL REPORTERS REPORT # (B)(6). PT SITTING UP FOR SPINAL ANESTHESIA BEING PERFORMED AND A PORTION OF THE SPINAL NEEDLE BROKE OFF INSIDE OF THE PATIENT. LS CT CONFIRMED RETAINED SPINAL NEEDLE. REMOVAL IN OR UNEVENTFULLY OF BENT SPINAL NEEDLE W7 POST OP IMAGING CONFIRMING NO RFO.
Patient problems: Foreign Body In Patient
MAUDE report 13288393 ↗
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
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- ARROW IPN922605Teleflex 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 IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922604Teleflex 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.