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); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a second insertion attempt was being made into the patient's left femoral in the emergency department.During insertion the guide wire kinked.As a result, a 20cm cvc kit was opened and placed successfully.

Manufacturer Narrative

(b)(4).This report is for the second in a series of two consecutive product problems with the same patient.The first issue has been reported under mdr # 3003737899-2016-00037.Device evaluation: the reported complaint of the guide wire became kinked during insertion was confirmed.The customer returned one guide wire and several other components in an opened kit.The introducer needle and the catheter were not returned.Visual examination of the guide wire revealed one kink at the distal end of the wire.The kink was measured at 2.5 cm from the distal weld.Microscopic examination confirmed the kink and that both welds were full and spherical.No other defects were observed.A manual tug test confirmed that both welds remain intact.The guide wire measured approximately 455mm in the total length and exhibited an outside diameter (od) measured 0.801 mm.The returned guide wire was within specification for length and od per graphic (length: 450 - 458 mm and od: 0.788- 0.826mm).The other returned components, an 18 ga catheter from a catheter over needle assembly, two arrow raulerson syringe (ars) and dilator, all appeared used since dried blood was observed on both the outside and inside of these components.Other remarks: functional testing was performed with the returned guide wire and each of these components separately.The guide wire passed through each component with no resistance.The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use.The device history record review was performed and did not reveal any manufacturing related issues.Since the guide wire is always inserted through another component and the introducer needle and catheter were not returned, the probable cause of this issue could not be determined.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: 5892037
• MDR Text Key: 52611794
• Report Number: 3003737899-2016-00038
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CA-42703-P1A
• Device Lot Number: 13F16A0201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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