SPROTTE® 021163-30CRecalls & reported problems
Pajunk GmbH Medizintechnologie · Needle · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048223114827), received between May 4, 2023 and May 4, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (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
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2023Device Handling Problem; Device Handling Problem
RN# 151_1-23_800. SUBJECT WAS BROUGHT TO SEDATION UNIT FOR IP/SHAM PROCEDURE. PHARMACY PROVIDED SPONSOR'S NRFIT NEEDLES TO BE USED PER PROTOCOL FOR THIS PROCEDURE, WHICH WERE DIFFERENT THAN THOSE USED ON THE PREVIOUS STUDY PATIENT FOR THE SAME PROCEDURE. SITE WAS IDENTIFIED BY PALPATION AND STERILIZED. THE PATIENT WAS SEDATED AND FIRST ATTEMPT AT CSF COLLECTION WAS PERFORMED AFTER SEDATION WAS ASSURED. UPON FIRST ATTEMPT USING THE PROVIDED NRFIT LP 22 G NEEDLE, THE PROVIDER WAS UNABLE TO ACCESS THE INTRATHECAL SPACE DUE TO THE INTRODUCER LENGTH AND INFLEXIBILITY. THE SECOND ATTEMPT WAS MADE USING THE 25 G NRFIT NEEDLE SET AND AGAIN, PROVIDER WAS UNABLE TO ACCESS THE INTRATHECAL SPACE USING THIS SPINAL NEEDLE SET. BLOOD WAS RETURNING AND THE CONCERN WAS THAT REPEATED ATTEMPTS WITH NRFIT NEEDLES WOULD RESULT IN POTENTIAL FOR EPIDURAL HEMATOMA. THERE WERE CONCERNS THAT THE NRFIT NEEDLES WOULD NOT APPROPRIATELY ACCESS THE INTRATHECAL SPACE. THE PROCEDURE WAS CONTINUED WITH COMMERCIAL/STANDARD LP NEEDLE 22G X 1.5 IN. THE INTRATHECAL SPACE WAS ACCESSED EASILY WITH STANDARD NEEDLE AND 3 CC OF CSF WAS COLLECTED FOR PROCESSING. (B)(4) IP WAS PREPPED TO CONNECT TO THE NEEDLE SET FOR INJECTIO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16866119 ↗
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
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- 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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