SPROTTE® NRFit 021163-29A (UDI 14048223026950)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14048223026950), received between Jan 19, 2018 and Aug 5, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IRN#:(B)(4). WHILST PERFORMING A SPINAL ANAESTHETIC THE PLASTIC HUB OF THE NEEDLE BROKE AWAY FROM THE METAL NEEDLE, LEAVING THE METAL NEEDLE STICKING OUT OF THE PATIENTS BACK. NO EXCESSIVE FORCE WAS USED. THIS IS THE ONLY REPORT OF SUCH AN INCIDENT IN OUR ANAESTHETIC DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10369803 ↗
• MalfunctionJun 19, 2019Break; Break

  (B)(4). NEEDLE BREAKAGE WHILE A SPINAL WAS IN PROCESS. IT BENT WHERE THE NEEDLE LEFT THE INTRODOCER. AFTER STRAIGHTENED OUT THE NEEDLE BROKE. BROKEN END REMOVED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8710526 ↗
• MalfunctionApr 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IRN# 620_109-19. INITIAL REPORTER´S NARRATIVE: PATIENT ON ELECTIVE CAESAREAN SECTION LIST. STRAIGHTFORWARD SPINAL USING THE NR FIT PAJUNK SPROTTE 25G 90MM NEEDLE VIA THE SUPPLIED 30MM INTRODUCER NEEDLE. INJECTED SPINAL DRUGS UNEVENTFULLY. ATTEMPTED TO REMOVE THE INTRODUCER AND SPINAL NEEDLE AS A SINGLE UNIT WHEREUPON THE HUB OF THE SPINAL NEEDLE DETACHED FROM THE NEEDLE LEAVING THE NEEDLE PROTRUDING FROM THE PATIENT'S BACK. THE NEEDLE WAS SUBSEQUENTLY REMOVED MANUALLY AND WAS INTACT.

  Patient problems: Inadequate Pain Relief; No Known Impact Or Consequence To Patient

  MAUDE report 8502928 ↗
• MalfunctionFeb 13, 2019Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  IRN# 610_048-19 . INITIAL REPORTERS NARRATIVE: WHILST PERFORMING A SPINAL THE CLINICIAN EXPERIENCED THE HUB BREAKING/COMING AWAY FROM THE NEEDLE LEAVING THE DISTAL PART IN THE PATIENT WHICH WAS RETRIEVED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8334602 ↗
• MalfunctionJan 19, 2018Failure To Adhere Or Bond; Fracture; Failure To Adhere Or Bond; Fracture

  (B)(4). INITIAL REPORTER´S NARRATIVE: DISTAL END CAME OFF.

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

  MAUDE report 7204920 ↗