MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER, SUBCLAVIAN

Catalog Number CS-15122-F

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

Event Description

The customer alleges that the swg (spring wire guide) was found kinked when opening the kit.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there were multiple components in the kit including the guide wire in the advancer assembly with the cap.Two kinks were observed in the guide wire near the straightening assembly within the advancer and the straightening assembly exhibited signs of use.The guide wire was removed from the assembly and examined.Microscopic examination revealed signs of use within the guide wire also.Two kinks were confirmed and both welds appeared full and spherical.No other damage was observed.The guide wire measured 684 mm in length, which meets the length specification.The diameter of the guide wire measured 0.863 mm using which is also within specification.The kinks were measured at 1.5 and 4.2 cm from the distal end of the core wire.A manual tug test confirmed that both welds remains intact.A device history record (dhr) review was performed on the guide wire with no relevant findings.Other remarks: the reported complaint of the guide wire was found kinked was confirmed through examination of the returned sample.The guide wire exhibited two kinks; however, the returned wire and assembly exhibited signs of use and could not have been found in the kit in this condition as reported by the customer.A dhr review did not reveal any manufacturing related issues.Based upon the condition of the returned sample, it was determined that operational context appeared to have caused or contributed to the event.

Event Description

The customer alleges that the swg (spring wire guide) was found kinked when opening the kit.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6490611
• MDR Text Key: 72801105
• Report Number: 3006425876-2017-00131
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 71F16H1180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• 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