MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW TWO-LUMEN HEMODIALYSIS CATHETERIZATION KIT; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number CDC-25142-X1A

Device Problems Material Frayed (1262); Physical Resistance/Sticking (4012)

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

Event Date 04/28/2020

Event Type  malfunction  

Event Description

Arrowgard blue two lumen hd cath kit 14f, lot 23f19l0486, exp 02/28/2021, ref cdc-25142-x1a: "during initial attempt, guidewire became stuck, attempt to withdraw resulted in guidewire fraying completely.Wire completely removed from patient and new attempt was made with new guidewire which passed easily.".

• Brand Name: ARROW TWO-LUMEN HEMODIALYSIS CATHETERIZATION KIT
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10042526
• MDR Text Key: 190496925
• Report Number: 10042526
• Device Sequence Number: 1
• Product Code: MPB
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-25142-X1A
• Device Lot Number: 23F19L0486
• 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: 05/01/2020
• Date Report to Manufacturer: 05/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1