Design Options® 555083Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964313493), received between Sep 21, 2017 and Jan 6, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: TIP OF CATHETER BROKE OFF - APPROX 1 CM LEFT INSIDE OF PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16115831 ↗
• InjuryApr 16, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: AS THE DOCTOR WAS PERFORMING THE EPIDURAL, QUESTIONABLE LOSS OF RESISTANCE OCCURRED. THE CATHETER WAS ADVANCED TO ABOUT 22 CM. AS THE CATHETER WAS BEING WITHDRAWN, SOME RESISTANCE WAS FELT AND THE DOCTOR GENTLY TUGGED ON THE CATHETER. AFTER THE WITHDRAWAL OF THE CATHETER, THE DOCTOR NOTICED IT WAS CUT AT THE 9 CM MARK. THE TUOHY NEEDLE WAS NOT CHECKED TO SEE IF THE CATHETER WAS LEFT IN THE NEEDLE WHICH COULD HAVE BEEN POSSIBLE SINCE THE TUOHY NEEDLE IS 10 CM LONG. THE CATHETER DID NOT GO INTRATHECALLY. THE PROCEDURE WAS THEN ABORTED. THE PATIENT HAD AN UNEVENTFUL VAGINAL DELIVERY SHORTLY THEREAFTER. A CAT SCAN WAS CONDUCTED BUT FAILED TO LOCATE THE CATHETER. THE DOCTOR CONSULTED THE NEUROSURGEON AND THE NEUROSURGEON STATED TO DO NO FURTHER INTERVENTION. THE PATIENT HAS HAD NO SYMPTOMS OR COMPLAINTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 7432340 ↗
• MalfunctionSep 21, 2017Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED BY THE USER FACILITY: EVENT 1: REPORTS NEEDLE STUCK THROUGH CAP CAUSING NEEDLE STICK WITH CONTAMINATED NEEDLE INCIDENT # 1: CUSTOMER REPORTS THAT, WHILE PLACING AN EPIDURAL CATHETER WITH ONE OF THE PERIFIX EPIDURAL ANESTHESIA TRAYS FOR A LABORING PATIENT, UPON RECAPPING THE 5/8TH INCH 25 G NEEDLE USED FOR LOCALIZING THE SKIN, THE NEEDLE WENT RIGHT THROUGH THE SIDE OF THE PLASTIC NEEDLE CAP AND PUNCTURED THE LEFT THUMB, CAUSING A PAINFUL NEEDLE STICK THAT DREW BLOOD. THE CLINICIAN QUICKLY DUMPED THE CONTAMINATED NEEDLE AND 3 CC SYRINGE, REWASHED MY HANDS, REGLOVED AND FINISHED THE PLACEMENT OF THE EPIDURAL. INCIDENT #2: UPON RECAPPING A 25 G NEEDLE PUNCTURING THE SIDE OF THE NEEDLE CAP STICKING THE CLINICIAN WITH CONTAMINATED BLOOD, THIS TIME TO THE LEFT INDEX FINGER. EVENT 2: WILL BE REPORTED VIA COMPLAINT NUMBER (B)(4) / MEDWATCH NUMBER 2523676-2017-00148.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6882758 ↗
• MalfunctionSep 21, 2017Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED BY THE USER FACILITY: EVENT 2: REPORTS NEEDLE STUCK THROUGH CAP CAUSING NEEDLE STICK WITH CONTAMINATED NEEDLE INCIDENT #2: UPON RECAPPING A 25 G NEEDLE PUNCTURING THE SIDE OF THE NEEDLE CAP STICKING THE CLINICIAN WITH CONTAMINATED BLOOD, THIS TIME TO THE LEFT INDEX FINGER. INCIDENT # 1: CUSTOMER REPORTS THAT, WHILE PLACING AN EPIDURAL CATHETER WITH ONE OF THE PERIFIX EPIDURAL ANESTHESIA TRAYS FOR A LABORING PATIENT, UPON RECAPPING THE 5/8TH INCH 25 G NEEDLE USED FOR LOCALIZING THE SKIN, THE NEEDLE WENT RIGHT THROUGH THE SIDE OF THE PLASTIC NEEDLE CAP AND PUNCTURED THE LEFT THUMB, CAUSING A PAINFUL NEEDLE STICK THAT DREW BLOOD. THE CLINICIAN QUICKLY DUMPED THE CONTAMINATED NEEDLE AND 3 CC SYRINGE, REWASHED MY HANDS, REGLOVED AND FINISHED THE PLACEMENT OF THE EPIDURAL. EVENT 1: WILL BE REPORTED VIA COMPLAINT NUMBER (B)(4) / MEDWATCH NUMBER 2523676-2017-00135.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6882748 ↗