SPROTTE® NRFit 211163-29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14048223030315), received between May 3, 2018 and May 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2018Fluid/Blood Leak; Crack; Fluid/Blood Leak; Leak/Splash

  (B)(4). FROM INITIAL REPORTER´S NARRATIVE: TWO X IDENTICAL INCIDENTS (B)(6) 2018 AND (B)(6) 2018: SPINAL ANAESTHESIA TO PATIENTS UNDERGOING ELECTIVE CAESAREAN SECTION. THE SPINAL NRFIT SPROTTE 25G NEEDLE WAS INSERTED AND CSF WAS ASPIRATED APPROPRIATELY. ON INJECTION OF THE SPINAL ANAESTHETIC SOLUTION, LEAKAGE FROM THE HUB OF THE NEEDLE WAS NOTED. POTENTIALLY INSUFFICIENT ANAESTHETIC WAS INJECTED INTO THE PATIENT. ON CLOSE INSPECTION OF THE 2 NEEDLES THERE WAS AN IDENTICAL PATTERN HAIRLINE CRACK IN THE HUB OF THE NEEDLE. WE HAVE RECENTLY CHANGED THE DESIGN AND PROCUREMENT OF OUR SPINAL NEEDLES, AND SWITCHED TO NRFIT SPROTTE NEEDLES PRODUCED BY PAJUNK. A CRACKED SPINAL NEEDLE HAS THE POTENTIAL TO CAUSE INADEQUATE SPINAL ANAESTHESIA LEADING TO INTRAOPERATIVE PAIN AND DISTRESS AND AN UNANTICIPATED GENERAL ANAESTHETIC.

  Patient problems: Inadequate Pain Relief; Underdose

  MAUDE report 7482185 ↗