MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 8 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-25802-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 in anesthesia, resistance was met when inserting the guide wire through the arrow raulerson syringe, resulting in the guide wire kinking.As a result, a 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 report that the guide wire kinked during insertion was confirmed.Returned by the customer was one arrow ra ulerson syringe (ars), one marked guide wire and one introducer needle.Visual inspection of guide wire, ars and introducer needle was performed.The guide wire had an opened j-tip and was 603 mm in length (rule: ga-ln-0560-003), with one kink at 27 cm from the distal tip.The outer diameter (od) measured 0.790 mm.A manual tug test confirmed that both welds remain intact.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 of the guide wire confirmed the kink wire.Visual inspection of the ars/needle assembly was performed and the needle appeared typical but used; however, the ars cannula's blue tip was dislodged from the barrel tip and was retracted into the barrel.The plunger was stuck on the cannula.Force was applied to move the plunger on the cannula and the cannula was retracted further into the plunger.The ars is designed to have the cannula tip remain secure within the barrel tip.A functional test was performed in an attempt to verify the complaint using the returned guide wire and the ars and the needle.Other remarks: the guide wire was inserted into the ars and it passed through the cannula without resistance.The guide wire also passed through the needle cannula withoutresistance.The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use.A device history records review was performed with no findings relevant to the complaint.Functional testing did not reveal any resistance between the returned guide wire and both the ars and introducer needle; however, the ars cannula and tip was detached from the syringe barrel.Based on these circumstances, the cause of this complaint is manufacturing- related.Further investigation of this issue has been initiated.

• Brand Name: CVC SET: 2-LUMEN 8 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: 5701153
• MDR Text Key: 46663182
• Report Number: 1036844-2016-00305
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 23F15H0237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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