SPROTTE® 021251-29ARecalls & reported problems
Pajunk GmbH Medizintechnologie · Needle · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048223114858), received between Apr 30, 2025 and Jul 8, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN ITALY. DURING THE SPINAL ANESTHESIA PROCEDURE, THE NEEDLE DISTAL PORTION BROKE, ABOUT 3 CM IMMEDIATELY AFTER STARTING THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 22436793 ↗InjuryJul 8, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN GERMANY. NEEDLE BROKEN AFTER BONE CONTACT.
Patient problems: Foreign Body In Patient
MAUDE report 22436792 ↗MalfunctionApr 30, 2025Break; Break
(B)(4). INCIDENT OCCURRED IN ITALY: DURING THE INSERTION OF THE INTRODUCER, AFTER AN INITIAL DIFFICULTY DUE TO AN OBSTACLE (POSSIBLY A CALCIFIED YELLOW LIGAMENT?), I WAS ABLE TO INSERT THE ENTIRE INTRODUCER WITHOUT DIFFICULTY. HOWEVER, I THEN ENCOUNTERED AN INABILITY TO ADVANCE THE INTRODUCER NEEDLE. UPON REMOVAL OF THE INTRODUCER, I FOUND THAT IT HAD BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934418 ↗
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- 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 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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