SPROTTE® NRFit 001163-30ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14048223029821), received between Jan 19, 2018 and Jul 2, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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.

• MalfunctionJul 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  (B)(4). NEEDLE LEAKING AT THE JOINT OF HUB AND METAL NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654099 ↗
• InjuryMar 27, 2018Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Handling Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Handling Problem

  (B)(4). DR (B)(6) WAS SUPERVISING DR (B)(6) USING NRFIT 24G X 90 SPROTTE SPINAL NEEDLE. INTRODUCER WAS PLACED AND SPINAL NEEDLE THEN INSERTED UP TO THE HILT AS PATIENT WAS QUITE LARGE (STATED AS OBESE). ON ATTEMPTING TO REMOVE THE PURPLE STYLET TO OBSERVE FOR CSF, THIS COULD NOT BE ACHIEVED SO DR (B)(6) WAS ADVISED TO REMOVE ALL PARTS AND START AGAIN. ON DOING THIS THE DAMAGE TO THE SPROTTE WAS NOTED AND PUT ASIDE. ANOTHER SET WAS OPENED AND USED WITHOUT INCIDENT. ANOTHER SET FROM SAME LOT NUMBER WAS OPENED AND EXAMINED AND DAMAGE COULDN'T BE REPLICATED BY HAND. DR (B)(6) HAS ISOLATED THE DAMAGED ITEM AND SET ASIDE FOR COLLECTION AND WILL ALSO SALVAGE THE PACKAGING TOO.

  Patient problems: Pain

  MAUDE report 7372802 ↗
• MalfunctionJan 19, 2018Crack; Fluid/Blood Leak; Nonstandard Device; Crack; Fluid/Blood Leak; Nonstandard Device

  (B)(4). INITIAL REPORTER´S NARRATIVE: 24G X 90MM SPROTTE NRFIT INTRODUCED TO SUBARACHNOID SPACE, ON INJECTION IMMEDIATELY LEAKED FROM SIDE OF HUB, TRIED TWICE WITH SAME VERY OBVIOUS RESULT. NEEDLE REMOVED AND REPLACED FOR USE WITH SUCCESSFUL COMPETITION

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7204922 ↗
• MalfunctionJan 19, 2018Bent; Manufacturing, Packaging or Shipping Problem; Device Handling Problem; Bent; Manufacturing, Packaging or Shipping Problem; Device Handling Problem

  (B)(4). INITIAL REPORTER´S NARRATIVE: ON RECEIPT THE NEEDLES WERE FOUND TO BE BENT BETWEEN HUB AND INTRODUCER MAKING THE USE/CONTROL OF THE NEEDLE DIRECTION IMPOSSIBLE, THEY WERE PUT ASIDE AND NOT USED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7204921 ↗