MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, CONDUCTION, ANESTHETIC

Model Number IPN045607

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/06/2020

Event Type  malfunction  

Event Description

Epidural placed by anesthesia for labor patient.After delivery nurse attempted to remove catheter but met resistance, called anesthesia who came to the bedside.While attempting removal of catheter, piece broke off of end and remained in patients back.

• Brand Name: ARROW
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10074467
• MDR Text Key: 191559974
• Report Number: 10074467
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2020,04/07/2020

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: Health Professional
• Device Model Number: IPN045607
• Device Catalogue Number: AK-05502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2020
• Date Report to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Weight: 90