Perifix® 333540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964180026), received between Mar 5, 2018 and Aug 3, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: FEMALE PATIENT HAD AN EPIDURAL REMOVED AND THE END WAS MISSING. END OF THE CATHETER SEEMED TO BE SHEARED OFF THERE WAS APPROXIMAL 0.5 CENTIMETER MISSING FROM THE END.

  Patient problems: Foreign Body In Patient

  MAUDE report 17449598 ↗
• MalfunctionAug 25, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: THE PATIENT UNDERWENT BILATERAL PARAVERTEBRAL NERVE BLOCKS CATHETER PLACEMENT. DURING THE CATHETER PLACEMENT OF THE LEFT SIDE, RESISTANCE WAS ENCOUNTERED WHEN THE CATHETER WAS ADVANCING VIA A TOUHY PAJUNCK CATHETER, 18 GAUGE. IT SEEMED THE CATHETER WAS NOT COMING OUT OF THE NEEDLE. AT THIS POINT [THE CUSTOMER ATTEMPTED] TO REMOVE BOTH, NEEDLE AND CATHETER, AS A UNIT. AFTER BOTH WERE REMOVED, A MISSING BROKEN CATHETER PIECE WAS NOTICED. [CUSTOMER] FELT A CRUNCH SENSATION WHILE REMOVING BOTH. CUSTOMER THEN DECIDED TO ATTEMPT A REMOVAL OF CATHETER BUT FRAGMENT COULD NOT BE VISUALIZED VIA ULTRASOUND, FLUOROSCOPY, OR DURING THE PATIENT'S SUBSEQUENT TOTAL SPINE MRI. TWO POTENTIAL LOT NUMBERS PROVIDED: LOT NUMBER 0061721766; EXPIRY DATE 12/31/2022; PRODUCTION DATE 01/27/2020. LOT NUMBER 0061713480; EXPIRY DATE 02/28/2023; PRODUCTION DATE 03/09/2020.

  Patient problems: Foreign Body In Patient

  MAUDE report 10451403 ↗
• InjuryMar 5, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: DURING REMOVAL OF THE CATHETER, THE TIP OF THE EPIDURAL CATHETER BROKE OFF AND WAS RETAINED IN THE PATIENT. NO RESISTANCE WAS MET DURING REMOVAL. IT WAS CONCLUDED THAT ONLY THE MOST DISTAL END WAS RETAINED. X-RAYS WERE PERFORMED ON THE PATIENT, HOWEVER, NO CONCLUSIONS COULD BE MADE. A CT SCAN WAS THEN PERFORMED WHICH SHOWED THE CATHETER TIP LOCATION TO BE AT L2. IT WAS DETERMINED TO MONITOR THE PATIENT AS NEEDED. THE PATIENT WAS ASYMPTOMATIC AND WAS DISCHARGED HOME THE SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7313193 ↗