Design Options® 552155Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046955214440), received between Apr 3, 2024 and Jul 17, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 5, 2023Open, Classified

   Kits were assembled with the incorrect Filter Straw.

   Z-2003-2023 · Root cause: Mixed-up of materials/components · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024

  EPIDURAL CATHETER BECAME DISCONNECTED AT ALLIGATOR CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759954 ↗
• MalfunctionJun 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  EVENT 1: AS REPORTED ON MEDWATCH (B)(4): PATIENT'S EPIDURAL CATHETER DISCONNECTED BY TEARING NEAR THE HUB WHERE IT CONNECTS FROM THE PUMP TO PATIENT. INSERTION SITE WAS INTACT.

  Patient problems: Pain

  MAUDE report 19508853 ↗
• MalfunctionJun 11, 2024Break; Break

  EVENT 2: AS REPORTED ON MEDWATCH (B)(4): ANESTHESIA TUBING WAS FOUND SNAPPED IN BED.

  Patient problems: Pain

  MAUDE report 19508852 ↗
• MalfunctionJun 5, 2024Break; Break

  AS REPORTED IN MEDWATCH (B)(4): DESCRIBE THE EVENT OR PROBLEM: EPIDURAL TUBING BROKE OFF WHILE EPIDURAL CATHETER WAS STILL IN PLACE INSIDE PATIENT'S BACK. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : EPIDURAL WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472066 ↗
• MalfunctionMay 23, 2024

  EPIDURAL TUBING BROKE OFF WHILE EPIDURAL CATHETER WAS STILL IN PLACE INSIDE PATIENT'S BACK.

  Patient problems: Foreign Body In Patient

  MAUDE report 19380389 ↗
• MalfunctionApr 15, 2024

  PATIENT CALLED OUT STATING THAT SHE WAS IN PAIN AND THE EPIDURAL WAS NOT WORKING; RN (REGISTERED NURSE) FOUND THE EPIDURAL CATHETER TUBING TO BE DISCONNECTED FROM THE ALLIGATOR CLIP AND WAS INFUSING INTO THE FLOOR. RN CONSULTED ANESTHESIA IMMEDIATELY AND MD STERILELY CUT AND RECLAMPED EPIDURAL CATHETER. PATIENT WAS REBOLUSED AT THAT TIME.

  Patient problems: Pain

  MAUDE report 19104273 ↗
• MalfunctionApr 3, 2024

  FOUR REPORTS: (ALL WITH DIFFERENT PROVIDER INSERTIONS). PATIENT HAD AN EPIDURAL THAT HAD PREVIOUSLY BEEN WORKING WELL. SHE THEN BEGAN COMPLAINING OF INCREASED PAIN AND PRESSURE. RN (REGISTERED NURSE) ASSISTED PATIENT WITH POSITION CHANGE AND NOTICED A WET SPOT ON THE SHEET UNDER THE PATIENT. RN NOTICED THE EPIDURAL CATHETER WAS DISCONNECTED FROM THE ALLIGATOR CLIP AND LYING THE BED. PATIENT REPORTED HEARING A POP ON HER BACK. THE WHITE CAP HAD DISCONNECTED FROM THE LINE GOING TO THE PATIENT. FLUID LEAKING FROM THE PATIENT. EPIDURAL WAS TAKEN OUT AND REPLACED. PATIENT¿S EPIDURAL CATHETER DISCONNECTED BY TEARING NEAR THE HUB WHERE IT CONNECTS FROM THE PUMP TO PATIENT. INSERTION SITE WAS INTACT. ANESTHESIA TUBING WAS FOUND SNAPPED IN BED.

  Patient problems: Pain

  MAUDE report 19031379 ↗