SPROTTE® 211163-29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048223116470), received between Feb 14, 2025 and Jul 18, 2025 — classified as 1 injury, 2 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Break; Break

  IRN# (B)(4) INCIDENT OCCURRED IN UK: PANJUNK SPROTTE 25X90MM NEEDLE BROKE WHILE PULLING OUT, HOWEVER ENTIRE NEEDLE COULD BE RETRIEVED.CONFIRMED BY -NOTING BEVEL AT DISTAL END, COMPARING LENGTH OF BROKEN PARTS WITH ANOTHER NEEDLE (90MM). REPORTER NOTES - "IDON'T THINK THERE WAS NOT ANY EXCESSIVE FORCE INVOLVED. JUST A ROUTINE SPINAL WITH MILD DIFFICULTY DUE TO HIGH BMI. THE NEEDLE BREAK IN SUCH CASE RAISES CONCERN. I DON'T THINK THINGS COULD HAVE BEEN DONE DIFFERENTLY FROM POINT OF VIEW OF TECHNIQUE, HUMAN FACTORS ETC" BMI 40+.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539491 ↗
• MalfunctionFeb 14, 2025Obstruction of Flow; Obstruction of Flow

  IRN# (B)(4) INCIDENT OCCURRED IN GREAT BRITAIN: NEEDLE WAS USED ON A PATIENT BY AN ANAESTHETIST BUT WAS UNABLE TO INJECT DOWN THE NEEDLE. THE NEEDLE WAS REPOSITIONED THREE TIMES BUT HAD NO FLOW OF CSF WITH EACH ATTEMPT. THE NEEDLE WAS ASSUMED TO BE BLOCKED AND A NEW NEEDLE WAS USED FROM THE SAME BATCH. THE NEW NEEDLE HAD NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21382816 ↗
• MalfunctionFeb 14, 2025Nonstandard Device; Difficult or Delayed Separation; Device Stenosis; Nonstandard Device; Difficult or Delayed Separation; Device Stenosis

  (B)(4). INCIDENT OCCURRED IN GREAT BRITAIN: SPINAL NEEDLE BEING USED IN DELIVERY SUITE FOR LABOURING PATIENT. ON WITHDRAWING THE INTRODUCER IT GOT STUCK IN THE NEEDLE SO THE ENTIRE NEEDLE AND INTRODUCER REMOVED AND A FRESH ONE USED. A NEW NEEDLE USED - PATIENT UNNECESSARILY HAD TWO SPINAL NEEDLE PASSES. ON EXAMINING THE FAULTY NEEDLE, THERE APPEARS TO BE EXCESS FRICTION BETWEEN THE SPINAL NEEDLE AND THE INTRODUCER IMPLYING THAT THE SPINAL NEEDLE HAS A NARROWING. THE INTRODUCED COULD BE REMOVED (OUTSIDE OF THE PATIENT) BUT THEN THE SPINAL NEEDLE COULD NOT BE FLUSHED WITH SALINE EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21382653 ↗