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

Catalog Number AK-05502

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2019

Event Type  malfunction  

Event Description

Epidural catheter was being removed when it appeared that part broke off.A fragment approximately 1.8 cm below the skin surface slightly left of midline at l3-4 level was observed in ct imaging study.

• Brand Name: FLEXTIP PLUS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bemville rd; reading PA 19605
• MDR Report Key: 8463840
• MDR Text Key: 140349221
• Report Number: 8463840
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19A0239
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8395 DA
• Patient Weight: 68