SPROTTE® 021163-29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048223114803), received between May 4, 2023 and Nov 26, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “No Flow” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IRN# (B)(4). COMPLAINT TOOK PLACE IN UNITED KINGDOM. IN THE PROCESS OF ADMINISTERING SINGLE SHOT SPINAL ANAESTHESIA ON TWO OCCASSIONS (SAME PATIENT) THE DR BENT THE SPROTTE (PHOTO ATTACHED). WHEN DESCRIBED HE WAS REASONABLY SURE HE HAD NOT HIT BONE, THOUGH I AM NOT SO SURE. HE SUCCESSFULLY USED ANOTHER NEEDLE TO COMPLETE AND THEN FOR THE FOLLOWING CASE WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785478 ↗
• MalfunctionJul 9, 2024Nonstandard Device; No Flow; Nonstandard Device; No Flow

  IRN# (B)(4) DEVICE WAS BEING USED TO ADMINSTER SPINAL ANAESTHESIA FOR A EMERGENCY LOWER SEGMENT CAESAREAN SECTION. ANAESTHETIST WAS UNABLE TO INJECT THROUGH THE DEVICE AFTER FEELING LOSS OF RESISTANCE /GIVE. DEVICE WAS REMOVED. IT WAS NOTED THAT THE SPINAL NEEDLE DID NOT HAVE ANY HOLES AT THE TIP WHICH SHOULD HAVE HELPED TO INJECT THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700818 ↗
• MalfunctionJul 5, 2024Nonstandard Device; No Flow; Nonstandard Device; No Flow

  IRN# (B)(4). PATIENT ATTENDED MATERNITY THEATRES FOR AN ELECTIVE LSCS UNDER SPINAL ANAESTHESIA. DURING ATTEMPTS AT INSERTING A SPINAL NEEDLE NO CSF WAS FREELY DRAINING FROM THE SPINAL NEEDLE AT WHICH POINT A DIFFERENT OPERATOR USED A NEW NEEDLE AND WAS ABLE TO GIVE A SPINAL ANAESTHETIC. THE CASE PROCEEDED FOLLOWING THIS. UPON INSPECTION OF THE ORIGINAL NEEDLE THERE APPEARED TO BE NO APERTURE ON THE SIDE OF THE NEEDLE TO ALLOW PASSAGE OF CSF OR INJECTION OF INTRATHECAL MEDICATION. IT WAS NOT POSSIBLE TO INJECT ANY SALINE THROUGH THE NEEDLE UPON INSPECTION OF THE NEEDLE IN THE ANAESTHETIC ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678670 ↗
• MalfunctionMay 4, 2023Device Handling Problem; Device Handling Problem

  IRN# (B)(4). 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. OAV101B12301 IP WAS PREPPED TO CONNECT TO THE NEEDLE SET FOR INJECTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16866123 ↗