Design Options® 552122Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04046955056842), received between Jun 16, 2017 and Aug 16, 2018 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2018Break; Break

  AS PER MEDWATCH NUMBER (B)(4): EVENT DESCRIPTION: A. B. BRAUN 19 GAUGE EPIDURAL CATHETER WAS PLACED WITHOUT DIFFICULTY IN AN OBSTETRICS (OB) PATIENT DURING LABOR FOR PAIN MANAGEMENT. THE PLACEMENT WAS UNEVENTFUL AND THE CATHETER WAS TAPED, TEST DOSED AND BLOUSED AS PER ROUTINE PROTOCOL. THERE WAS NOTHING REMARKABLE ABOUT THE PLACEMENT OF THE CATHETER. APPROXIMATELY 90 MINUTES AFTER THE CATHETER WAS PLACED, THE PATIENT WAS SITTING UP IN BED WITH THE ASSISTANCE OF HER NURSE AND THEY HEARD A SNAP. THE NURSE QUICKLY IDENTIFIED THAT THE EPIDURAL CATHETER SNAPPED APART/SHREDDED AND IMMEDIATELY CALL THE OB ANESTHESIA ATTENDING PHYSICIAN AND THE OB ANESTHESIA. ON INSPECTION, IT APPEARED THAT THE PLASTIC SHEATH COVERING THE SPRING WIRE BROKE INTO TWO PIECES. FORTUNATELY THE SPRING WIRE WAS COMPLETELY INTACT AND THE EPIDURAL/WIRE WERE EASILY REMOVED WITH NO CONCERNS OF A RETAINED CATHETER OR SPRING. THE PATIENT WAS CONCERNED THAT THE CATHETER BROKE WITH MINIMAL FORCE DURING A PATIENT POSITION CHANGE. A NEW EPIDURAL CATHETER WAS PLACED WITHOUT COMPLICATIONS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7791874 ↗
• MalfunctionOct 5, 2017Break; Break

  (B)(4). EVENT DESCRIPTION: THE PATIENT WAS UNDERGOING BLADDER SURGERY AND AN EPIDURAL WAS REQUESTED. THE CATHETER, ONCE PLACED, RESULTED IN LEAKING AROUND THE INSERTION SITE. WHEN THE PROVIDER ATTEMPTED TO REMOVE THE CATHETER, IT BROKE WITH ONLY A PORTION OF THE CATHETER BEING WITHDRAWN. NEUROSURGERY WAS CONSULTED AND THE PATIENT REQUIRED SURGICAL REMOVAL OF THE CATHETER FRAGMENT AND INTERNAL WIRE FRAGMENT. THERE WERE NO COMPLICATIONS FROM THE REMOVAL AND THE PATIENT WENT ON TO HAVE SURGERY WITHOUT AN EPIDURAL BEING PLACED. OF NOTE, ON A PLACEMENT ATTEMPT JUST PRIOR TO THIS INSERTION, A "WET TAP" OCCURRED. UPON REVIEW, AFTER SEEING A TREND OF WET TAPS, IT WAS DISCOVERED THAT THE WRONG NEEDLE WAS PLACED IN NEW EPIDURAL KITS THAT WERE ORDERED FROM THE MANUFACTURER. THE MANUFACTURER WAS NOTIFIED AND THE APPROPRIATE NEEDLES WERE TAPED TO THE EPIDURAL TRAYS UNTIL NEW TRAYS, WITH THE CORRECT NEEDLES, ARRIVED TO REPLACE THE CURRENT STOCK. THUS, THE PATIENT HAD TWO ISSUES WITH THE DEVICES IN THE EPIDURAL TRAY KIT DURING THE SAME PROCEDURE. OUR SYSTEM INDICATES THAT FOR PRODUCT 552122, (B)(4) WAS CREATED ON 5/31/2017 FOR LOR NEEDLE CAUSING DURA PUNCTURE ISSUES INVOLVING BLOOD PATCH INTERVEN

  Patient problems: Foreign Body In Patient

  MAUDE report 6919019 ↗
• MalfunctionJun 16, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: EVENT 7: LOR NEEDLE CAUSING DURA PUNCTURE. TUOHY NEEDLE DID NOT ACHIEVE LOSS OF RESISTANCE AND THE NEEDLE ADVANCED TO FAR CAUSING DURA PUNCTURE. AT LEAST TWO PATIENTS HAD TO HAVE A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648918 ↗
• MalfunctionJun 16, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: EVENT 6: LOR NEEDLE CAUSING DURA PUNCTURE. TUOHY NEEDLE DID NOT ACHIEVE LOSS OF RESISTANCE AND THE NEEDLE ADVANCED TO FAR CAUSING DURA PUNCTURE. AT LEAST TWO PATIENTS HAD TO HAVE A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648917 ↗
• MalfunctionJun 16, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: EVENT 5: LOR NEEDLE CAUSING DURA PUNCTURE. TUOHY NEEDLE DID NOT ACHIEVE LOSS OF RESISTANCE AND THE NEEDLE ADVANCED TO FAR CAUSING DURA PUNCTURE. AT LEAST TWO PATIENTS HAD TO HAVE A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648916 ↗
• MalfunctionJun 16, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: EVENT 3: LOR NEEDLE CAUSING DURA PUNCTURE. TUOHY NEEDLE DID NOT ACHIEVE LOSS OF RESISTANCE AND THE NEEDLE ADVANCED TO FAR CAUSING DURA PUNCTURE. AT LEAST TWO PATIENTS HAD TO HAVE A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648915 ↗
• MalfunctionJun 16, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: EVENT 4: LOR NEEDLE CAUSING DURA PUNCTURE. TUOHY NEEDLE DID NOT ACHIEVE LOSS OF RESISTANCE AND THE NEEDLE ADVANCED TO FAR CAUSING DURA PUNCTURE. AT LEAST TWO PATIENTS HAD TO HAVE A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648913 ↗
• MalfunctionJun 16, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: EVENT 2: LOR NEEDLE CAUSING DURA PUNCTURE. TUOHY NEEDLE DID NOT ACHIEVE LOSS OF RESISTANCE AND THE NEEDLE ADVANCED TO FAR CAUSING DURA PUNCTURE. AT LEAST TWO PATIENTS HAD TO HAVE A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648912 ↗
• MalfunctionJun 16, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: EVENT 1: LOR NEEDLE CAUSING DURA PUNCTURE. TUOHY NEEDLE DID NOT ACHIEVE LOSS OF RESISTANCE AND THE NEEDLE ADVANCED TO FAR CAUSING DURA PUNCTURE. AT LEAST TWO PATIENTS HAD TO HAVE A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 6648909 ↗