MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 16 CM AGB+; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CA-42703-P1A

Device Problems Kinked (1339); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheter was being placed into the left ij of a female patient in the emergency department.During insertion of the guide wire into the raulerson syringe, the wire easily kinked and became stuck.The wire appears to kink when entering the syringe and wile entering the hub of the needle.The patient was a trauma and was quite sick.She already had two iv's.When this occurred, the physician aborted the procedure.They do not know if there was a delay in treatment and there was no patient death or complications reported.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the customer reported that during insertion of the guide wire into the arrow raulerson syringe (ars), the guide wire kinks easily and gets stuck.It was also reported that the wire appears to kink when entering the syringe and the needle hub.The customer returned one guide wire and one ars.The introducer needle was not returned.Visual examination revealed the guide wire had one kink near the distal end and the ars appeared typical and the plunger moved freely.Microscopic examination of the guide wire revealed that both welds were observed to be full and spherical and no separations were observed.A tug on the wire at both ends confirmed the welds were intact.The swg length measured 457 mm and the outer diameter (od) measured 0.803 mm.Both measurements are within specifications per graphic (length: 450- 458 mm; od: 0.788-0.826mm).Microscopic examination of the ars revealed that no damage or defects was observed.A functional test was performed in an attempt to verify the complaint using the returned guide wire and ars.The guide wire was inserted into the ars four times each at a different orientation by rotating the syringe 1/4 turns at each insertion.Other remarks: and with the plunger in and out.The guide wire passed through each time and no resistance was met.The ifu for this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.A device history record review was performed on the returned components with no relevant findings.A device history record review found no evidence to indicate a manufacturing related cause.The probable cause of the guide wire meeting resistance during insertion into the ars and introducer needle could not be determined based upon the information provided and without a complete sample.No further action will be taken.

• Brand Name: PI CVC KIT: 3-L 7 FR X 16 CM AGB+
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5507956
• MDR Text Key: 40792679
• Report Number: 3003737899-2016-00005
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• 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: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: CA-42703-P1A
• Device Lot Number: 13F15H0209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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