MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 14 GA X 8" (20 CM); ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CV-04701

Device Problems Kinked (1339); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event was initially evaluated and determined to be non-reportable.The returned device was evaluated and the event was determined to be a result of a product malfunction, therefore it is reportable.This report is for the second in a series of two consecutive product issues occurring with the same patient.The initial event has been reported under mdr# 3006425876-2015-00343.

Event Description

It was reported that during insertion in the icu, the doctor stated that the guide wire was "too slippery" to be placed with one hand.As a result, another kit was opened and used without issue.The insertion site was the right subclavian.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint was confirmed through examination of a returned product sample.The customer provided a guide wire with an advancer assembly and a single lumen catheter.The guide wire had an opened j-bend and numerous kinks.The core wire was separated.Functional testing was performed by reinserting the guide wire into the assembly and advancing the wire.No difficulty was encountered.Additionally, proximal end of the wire was inserted into the distal end of the catheter.There was no evidence of a "slippery" wire and it was able to pass through without resistance.A review of manufacturing records did not yield any relevant findings.Operational context appears to have caused or contributed to this event.No further action will be taken.

• Brand Name: CVC SET: 14 GA X 8" (20 CM)
• Type of Device: ADULT MULTI LUMEN 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: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5214196
• MDR Text Key: 30883921
• Report Number: 3006425876-2015-00344
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K862056
• 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: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: CV-04701
• Device Lot Number: 71F14K0997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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
• Patient Age: 82 YR
• Patient Weight: 75