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

Model Number IPN046629

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 10/11/2019

Event Type  malfunction  

Event Description

Patient was positioned to remove epidural catheter.Resistance was met.Patient repositioned, mild resistance met as catheter was removed, felt a snap and catheter came out without tip intact.

• Brand Name: ARROW
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 9309471
• MDR Text Key: 165977890
• Report Number: 9309471
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: (01)50801902013694
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2019

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: IPN046629
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F19E0341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2019
• Date Report to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Weight: 117