MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EPIDURAL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number PACKAGED REFERENCE # 21-7349-2

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2020

Event Type  Injury  

Event Description

Epidural catheter connector damaged, detached from line.Line exposed.Fda safety report id # (b)(4).

• Brand Name: EPIDURAL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10482793
• MDR Text Key: 205495219
• Report Number: MW5096380
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PACKAGED REFERENCE # 21-7349-2
• Device Lot Number: 3967442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR