SPROTTE® 001151-30CRecalls & reported problems
Pajunk GmbH Medizintechnologie · SPROTTE® 22G x 3 1/2" (90mm), sterile · 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 14048223000059), received between Jul 18, 2017 and Jul 18, 2017 — 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.
Most reported problems
Device problems
- Break1
- Crack1
- Inadequacy of Device Shape and/or Size1
- Patient-Device Incompatibility1
Patient problems
- Inadequate Pain Relief1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2017Break; Crack; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Break; Crack; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility
IRN# (B)(4). FROM CUSTOMER EXPERIENCE FORM SENT BACK TO MFR: NEEDLE BENT. FROM MEDWATCH REPORT: EVENT DESC: PATIENT WAS ADMITTED TO LABOR AND DELIVERY FOR A C-SECTION. DURING REGIONAL ANESTHESIA PLACEMENT BY PHYSICIAN, THE SPINAL NEEDLE BROKE. AN APPROXIMATE THREE INCH SEGMENT OF THE NEEDLE REMAINED EMBEDDED IN PATIENT'S BACK. AFTER COMPLETION OF THE C-SECTION, THE NEEDLE WAS SUCCESSFULLY REMOVED BY THE PHYSICIAN. THE INCISION WAS CLOSED WITH SILVER NITRATE, SURGICAL SKIN GLUE, AND STERI STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL; NO COMPLICATIONS. THE INCIDENT WAS EXPLAINED TO THE PATIENT AND HER HUSBAND. PATIENT WAS DISCHARGED WITHIN NORMAL / EXPECTED TIME FRAME FOR C-SECTION WITH NO COMPLICATIONS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? REGIONAL ANESTHESIA.
Patient problems: Inadequate Pain Relief; Pain
MAUDE report 6720647 ↗
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- ARROW IPN923597Teleflex 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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