MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7FR X 16CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CV-22703-E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.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 # 3006425876-2016-00311.

Event Description

It was reported a second kit was then opened.A second needle stick was made.The guide wire was passed through the needle.The guide wire couldn't be removed from the catheter.As a result, a cvc from another manufacturer was used successfully.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the report that the guide wire couldn't be removed from the catheter was confirmed.Returned was a guide wire through a catheter marked 7fr x 16cm on the hub.The proximal end of the guide wire was protruding 7.2 cm from the distal end of the catheter.The guide wire was kinked 3 cm inside the distal end of the catheter.The guide wire was also kinked 5 cm from the bottom of the j-bend that was protruding from the proximal end of the catheter.A manual tug test confirmed that both welds were intact.The outside diameter (od) of the guide wire measured 0.801 mm, which met specification of 0.788 - 0.826 mm per the guide wire graphic.The length of the guide wire measured 45.5 cm, which was also consistent with the guide wire graphic.Attempts to remove the guide wire from either end of the catheter were unsuccessful.A review of the device history records did not reveal any manufacturing related issues.Based on the condition of the sample and the information provided, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: CVC SET: 3-LUMEN 7FR X 16CM
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5998351
• MDR Text Key: 56447442
• Report Number: 3006425876-2016-00312
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: CV-22703-E
• Device Lot Number: 71F16A0583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2016
• 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