MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT; CATHETER, HEMODIALYSIS, NON-IMPL.

Catalog Number CDC-25122-X1A

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the guidewire was found bent during incoming inspection.

Manufacturer Narrative

(b)(4).The customer returned an opened cdc-25122-x1a kit with various components, including a guide wire assembly for evaluation.None of the components showed evidence of use.Visual examination of the returned guide wire assembly revealed that the straightener tube was missing from the assembly and the end cap was secured upside down indicating the guide wire had been removed from the assembly at some point.Visual examination also revealed two kinks in the guide wire body.The kinks in the guide wire were observed to be in the location of the exposed wire section in the advancer thumb guide.This damage is consistent with the guide wire coming in contact with other components during shipping and handling.Both welds were observed to be full and spherical.The guide wire contained two kinks 41 and 59 mm from the distal end.The overall length and outer diameter of the returned guide wire were measured and were found to be within specification.Manual tug test confirmed both the distal and proximal welds are intact.A device history record review was performed on the kit including the spring wire guide and no relevant issues were identified.The report that the spring wire guide was found to be kinked prior to use was confirmed through visual examination of the returned sample.Visual examination revealed two kinks in the guide wire body.The damage observed is consistent with damage during transit.A device history record review was performed with no relevant findings.Based on the sample received, shipping and handling caused or contributed to this issue.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports the guidewire was found bent during incoming inspection.

• Brand Name: ARROW HEMODIALYSIS KIT
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPL.
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7515622
• MDR Text Key: 108363256
• Report Number: 1036844-2018-00140
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: CDC-25122-X1A
• Device Lot Number: 23F18A0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1