SPROTTE® 121151-27A (UDI 14048223001438)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14048223001438), received between Jan 19, 2018 and Sep 9, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionSep 9, 2020Material Separation; Material Separation

  IRN # (B)(4). TENTATIVE SUMMARIZING TRANSLATION OF INITIAL REPORTER´S NARRATIVE: WE RECEIVED TODAY COMPLAINT REGARDING SPROTTE NEEDLE RE. 121151-27A, LOT 1323. AFTER DRUG ADMINISTRATION TO THE SPINAL CANAL, THE NEEDLE HUB SEPARATED FROM THE NEEDLE IT GUT STUCK IN THE PATIENT'S SPINE. DOCTOR PULLED THE NEEDLE OUT WITH FORCEPS. EVENT HAPPENED TODAY (B)(6) 2020. PATIENT IS SAFE AN UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10506057 ↗
• MalfunctionAug 5, 2020Break; Break

  IRN#: (B)(4). SPINAL ANAESTHESIA WAS USED DURING C-SECTION. UPON REMOVAL, STAFF NOTICED THAT THE NEEDLE IS SHORT, A PART OF THE NEEDLE REMAINED INSIDE THE PATIENT. PATIENT WAS TRANSPORTED TO ANOTHER INSTITUTION, PUT UNDER X-RAY. THE NEEDLE WAS STUCK IN FAT TISSUE OUTSIDE OF VERTEBRAE. IT NEEDED TO BE REMOVED SURGICALLY VIA INCISION. A FOLLOW-UP X-RAY DETERMINED THAT THE PATIENT WAS METAL-FREE, THE SCAR TISSUE WAS IN THE PROCESS OF HEALING WITHOUT COMPLICATIONS. PATIENT WAS DISCHARGED TO HER HOME ON JULY 14TH. IN ADDITION TO THE REFERENCED AFFECTED QUANTITY OF 38 BELOW, THERE WERE SEVERAL NEEDLES THAT HAD BEEN BENT OR DEFORMED AS REPORTED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10369801 ↗
• MalfunctionJan 28, 2019Fracture; Fracture

  (B)(4). TENTATIVE TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: SECTIO, UNABLE TO GAIN ACCESS TO SPINAL SPACE L3/L4, UPON REMOVAL OF THE NEEDLE WITHOUT STYLET 40MM FROM THE DISTAL END ARE MISSING.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8283976 ↗
• MalfunctionJan 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  (B)(4). INITIAL REPORTER´S NARRATIVE: LEAKAGE AT THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204919 ↗