MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-27702-E

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion in the general ward, resistance was met when inserting the guide wire resulting in the kinking of the wire.As a result, a new kit was opened and used without issue.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the complaint of a kinked guide wire during insertion was confirmed.Returned by the customer was one guide wire with no additional components.A visual examination of the guide wire revealed an opened j-bend.A manual tug test confirmed that both welds remain intact.The guide wire measured 601 mm in length.The outside diameter (od) measured.078 mm.The returned guide wire was within specification for length and od per guide wire graphic length: 596 - 604 mm and od: 0.788- 0.826 mm).Microscopic examination revealed off-set coils at 1.3 cm from the distal tip with one kink at 2.3 cm.The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use.A device history records review was performed and did not reveal any manufacturing related issues.Since the guide wire is always inserted through another component such as an introducer needle, ars syringe, or introducer catheter and none of these components were returned, the probable cause of this issue could not be determined.No further action will be taken.

• Brand Name: CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5701066
• MDR Text Key: 46662962
• Report Number: 1036844-2016-00304
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

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: 08/31/2016
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 23F15D1340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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