SPROTTE® NRFit 121163-30ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 14048223026905), received between Oct 2, 2019 and Dec 8, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2020Nonstandard Device; Material Deformation; No Flow; Nonstandard Device; Material Deformation; No Flow

  (B)(4). CATEGORY ONE LSCS, SPINAL ANAESTHETIC. CLINICALLY STRAIGHTFORWARD SPINAL ANAESTHETIC, NO DIFFICULTY OBTAINING CLINICAL END POINT OF SPINAL NEEDLE INSERTION. ON REMOVING CENTRE PORTION OF SPINAL NEEDLE IT FELT VERY GRATEY, IT WAS NOT SMOOTH AS YOU WOULD EXPECT. NO CSF, SEEN FROM NEEDLE, WHICH WAS SURPRISING AS CLINICALLY I FELT I WAS IN THE CORRECT PLACE. SWITCHED TO NEW NEEDLE, WHICH I INSERTED THROUGH SAME INTRODUCER WITH NO OTHER ADJUSTMENTS. CENTRE PART REMOVED SMOOTHLY AS YOU WOULD EXPECT AND FREE FLOWING CSF WAS SEEN. SPINAL ANAESTHETIC SUCCESSFULLY. ON EXAMINING THE FIRST NEEDLE AFTER THE EVENT IT APPEARED BENT. THE EXACT SAME THING HAPPENED TO ME ON (B)(6) 2020, WITH A GRATEY SENSATION ON REMOVING CENTRE PORTION OF NEEDLE, NO CSF DESPITE GOOD CLINICAL END POINT, NEEDLE APPEARED BENT ON REMOVAL DESPITE NON DIFFICULT INSERTION. THE LOT NUMBERS (1324) ETC ARE IDENTICAL ON BOTH NEEDLES BUT THE HUB ON THE GRATEY ONE WAS A PALER PURPLE. ON EXAMINING THE SELECTION OF NEEDLES THERE WAS A MIXTURE OF ONES WITH A PALE AND DARKER PURPLE HUB ALL WITH IDENTICAL LOT NUMBERS. ON OPENING ANOTHER PALE PURPLE HUBBED NEEDLE, AGAIN THE CENTRE BIT WAS GRATEY TO REMOVE, NOT SMOOTH AS IT SH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964104 ↗
• MalfunctionDec 8, 2020Nonstandard Device; Material Deformation; No Flow; Nonstandard Device; Material Deformation; No Flow

  (B)(4). CATEGORY ONE LSCS, SPINAL ANAESTHETIC. CLINICALLY STRAIGHTFORWARD SPINAL ANAESTHETIC, NO DIFFICULTY OBTAINING CLINICAL END POINT OF SPINAL NEEDLE INSERTION. ON REMOVING CENTRE PORTION OF SPINAL NEEDLE IT FELT VERY GRATEY, IT WAS NOT SMOOTH AS YOU WOULD EXPECT. NO CSF, SEEN FROM NEEDLE, WHICH WAS SURPRISING AS CLINICALLY I FELT I WAS IN THE CORRECT PLACE. SWITCHED TO NEW NEEDLE, WHICH I INSERTED THROUGH SAME INTRODUCER WITH NO OTHER ADJUSTMENTS., CENTRE PART REMOVED SMOOTHLY AS YOU WOULD EXPECT AND FREE FLOWING CSF WAS SEEN. SPINAL ANAESTHETIC SUCCESSFULLY. ON EXAMINING THE FIRST NEEDLE AFTER THE EVENT IT APPEARED BENT. THE EXACT SAME THING HAPPENED TO ME ON (B)(6) 2020, WITH A GRATEY SENSATION ON REMOVING CENTRE PORTION OF NEEDLE, NO CSF DESPITE GOOD CLINICAL END POINT, NEEDLE APPEARED BENT ON REMOVAL DESPITE NON DIFFICULT INSERTION. THE LOT NUMBERS (1324) ETC ARE IDENTICAL ON BOTH NEEDLES BUT THE HUB ON THE GRATEY ONE WAS A PALER PURPLE. ON EXAMINING THE SELECTION OF NEEDLES THERE WAS A MIXTURE OF ONES WITH A PALE AND DARKER PURPLE HUB ALL WITH IDENTICAL LOT NUMBERS. ON OPENING ANOTHER PALE PURPLE HUBBED NEEDLE, AGAIN THE CENTRE BIT WAS GRATEY TO REMOVE, NOT SMOOTH AS IT S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964103 ↗
• MalfunctionDec 8, 2020Nonstandard Device; Material Deformation; No Flow; Nonstandard Device; Material Deformation; No Flow

  (B)(4). CATEGORY ONE LSCS, SPINAL ANAESTHETIC. CLINICALLY STRAIGHTFORWARD SPINAL ANAESTHETIC, NO DIFFICULTY OBTAINING CLINICAL END POINT OF SPINAL NEEDLE INSERTION. ON REMOVING CENTRE PORTION OF SPINAL NEEDLE IT FELT VERY GRATEY, IT WAS NOT SMOOTH AS YOU WOULD EXPECT. NO CSF, SEEN FROM NEEDLE, WHICH WAS SUPRISING AS CLINICALLY I FELT I WAS IN THE CORRECT PLACE. SWITCHED TO NEW NEEDLE, WHICH I INSERTED THROUGH SAME INTRODUCER WITH NO OTHER ADJUSTMENTS., CENTRE PART REMOVED SMOOTHLY AS YOU WOULD EXPECT AND FREE FLOWING CSF WAS SEEN. SPINAL ANAESTHETIC SUCCESSFULLY. ON EXAMINING THE FIRST NEEDLE AFTER THE EVENT IT APPEARED BENT. THE EXACT SAME THING HAPPENED TO ME ON (B)(6) 2020, WITH A GRATEY SENSATION ON REMOVING CENTRE PORTION OF NEEDLE, NO CSF DESPITE GOOD CLINICAL END POINT, NEEDLE APPEARED BENT ON REMOVAL DESPITE NON DIFFICULT INSERETION. THE LOT NUMBERS (1324) ETC ARE IDENTICAL ON BOTH NEEDLES BUT THE HUB ON THE GRATEY ONE WAS A PALER PURPLE. ON EXAMINING THE SELECTION OF NEEDLES THERE WAS A MIXTURE OF ONES WITH A PALE AND DARKER PURPLE HUB ALL WITH IDENTICAL LOT NUMBERS. ON OPENING ANOTHER PALE PURPLE HUBBED NEEDLE, AGAIN THE CENTRE BIT WAS GRATEY TO REMOVE, NOT SMOOTH AS IT S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964100 ↗
• MalfunctionOct 31, 2019Component Misassembled; Component Misassembled

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: "PATIENT REQUIRING SPINAL ANAESTHETIC. DIFFICULT TO DO, MULTIPLE NEEDLES USED. ONE NEEDLE MANAGED TO GET INTO CSF UNFORTUNATELY HAD A LEUR LOCK CONNECTION THEREFORE IT WAS NOT POSSIBLE TO INFILTRATE ANY MEDICATION. SUBSEQUENT NEEDLE HAD TO BE PASSED AND PATIENT SUFFERED AN UNNECESSARY DURAL PUNCTURE. ON INVESTIGATION AFTERWARDS IT APPEARED THE LEUR LOCK NEEDLE HAD BEEN IN AN NRFIT PACKAGE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260280 ↗
• MalfunctionOct 31, 2019Crack; Component Misassembled; Crack; Component Misassembled

  (B)(4). INITIAL REPORTER´S NARRATIVE: "UPON INJECTION OF THE SPINAL ANAESTHETIC IT WAS OBSERVED THAT THE HUB OF THE NEEDLE WAS CRACKED & SUBSEQUENTLY THE ANAESTHETIC WAS LEAKING & RUNNING DOWN THE HUB & NEEDLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9259874 ↗
• MalfunctionOct 24, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: CER: PERFORMED A SPINAL INJECTION AND ON THE REMOVAL OF THE NEEDLE FROM THE PATIENT THE NEEDLE HUB CAME AWAY FROM THE NEEDLE ITS SELF. THIS WAS A STRAIGHTFORWARD PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9231205 ↗
• MalfunctionOct 2, 2019Crack; Crack

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: AN INJECTION LEAKAGE OCCURED AROUND THE HUB OF THE 24G X 90MM SPROTTE NEEDLE.

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

  MAUDE report 9143778 ↗
• MalfunctionOct 2, 2019Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: PERFORMED SPINAL AS USUAL ALTHOUGH LIGAMNET WAS TOUGH, THE SPINAL WORKED FINE. ON REMOVAL OF THE SPINAL NEEDLE THE HUB WAS DETACHED FROM THE METAL PART. SURGICAL NEEDLE HOLDERS WERE REQUIRED TO REMOVE THE METAL PART OF THE NEEDLE FROM THE PATIENTS BACK.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9143775 ↗
• MalfunctionOct 2, 2019Crack; Crack

  IRN# (B)(4). INITIAL REPORTER´S NARRATIVE: LEAKAGE AT THE HUB NEEDLE CONNECTION UPON PRIMING OF NEEDLE. ALL OUTSTANDING NEEDLES OF AFFECTED LOT NUMBER HAVE BEEN COLLECTED FROM ALL CLINICAL AREAS AND STORES.

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

  MAUDE report 9143772 ↗