MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Catalog Number PAIN1580B

Device Problems Inadequacy of Device Shape and/or Size (1583); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

Crna at bedside for epidural placement.Epidural needle placed without difficulties, catheter attempted to be inserted but would not thread into needle.Catheter appeared different than usual, and noted to be larger than usually in kit and similar sized to epidural needle bore.New catheter obtained and placed without difficulty.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.
• MDR Report Key: 13061893
• MDR Text Key: 282815581
• Report Number: MW5106233
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAIN1580B
• Device Lot Number: 21ILA939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White