MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. TELEFLEX EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Model Number SJ-05501

Device Problem Fracture (1260)

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

Event Date 01/02/2020

Event Type  Injury  

Event Description

Epidural catheter fractured upon removal at end of operating room case resulting in retained 6 cm portion.Fda safety report id# (b)(4).

• Brand Name: TELEFLEX EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. ; reading PA 19605
• MDR Report Key: 9621545
• MDR Text Key: 176236323
• Report Number: MW5092390
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: SJ-05501
• Device Lot Number: 23F19K0039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2020
• 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: 53 YR
• Patient Weight: 119