MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; ANESTHESIA CONDUCTION KIT

Model Number IPN045700

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)

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

Event Date 11/17/2016

Event Type  malfunction  

Event Description

Md reported that he removed a labor epidural that was placed a day before.During removal, he encountered resistance.He gently applied traction and observed that the catheter was coming out.The catheter abruptly broke off, leaving a portion of the catheter retained.Resistance to pulling out epidural catheter - despite careful traction, catheter snapped.The patient required surgery to remove the retained piece of catheter.

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 6154346
• MDR Text Key: 61784839
• Report Number: 6154346
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: IPN045700
• Device Catalogue Number: ASK-05502-MGH
• Device Lot Number: 23F16GO399
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 23 YR