MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-22122-F

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Md was preparing the procedure and checked the product.The md found that the swg (spring wire guide) was bent.A new device was obtained.

Event Description

Md was preparing the procedure and checked the product.The md found that the swg (spring wire guide) was bent.A new device was obtained.

Manufacturer Narrative

Qn#(b)(4).The customer returned various components including a guide wire assembly for evaluation.The guide wire advancer and end cap were not returned.Visual examination of the guide wire revealed one slight curve near the distal tip.The returned guide wire contained one slight curve 10 mm from the distal tip.The total length of the returned guide wire measured 600 mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the returned guide wire measured to be 0.856 mm which is within specifications of 0.828-0.877 mm per product drawing.The returned guide wire was advanced through the returned catheter with minimal resistance.A manual tug test confirmed both welds were fully intact.A device history record review was performed with no relevant findings.The customer report of a bent guide wire was confirmed by complaint investigation of the returned sample.The guide wire passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.Based on the customer report and the appearance of the sample received, shipping and handling caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10245589
• MDR Text Key: 197971329
• Report Number: 3006425876-2020-00588
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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 Expiration Date: 08/26/2020
• Device Catalogue Number: CS-22122-F
• Device Lot Number: 71F18K0850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1