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

Catalog Number CV-22703

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2015

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.

Event Description

It was reported that during insertion in the icu, the user had an issue when passing the guide wire through the raulerson syringe / introducer needle.As it was impossible to retrieve just the guide wire, both the wire and syringe/needle were together removed and a new kit was opened and used without issue.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 guidewire that was observed to be kinked near the distal end.The introducer needle and raulerson syringe were not returned.The guide wire was found to be intact and within dimensional specifications.No other damage or defects were observed.A device history record review was performed on the guide wire, introducer needle and ars with no relevant findings.The ifu for this product cautions that if resistance is encountered while advancing or withdrawing the guide wire do not use force and warns not to retract the guide wire against the edge of needle while in a vessel to minimize spring guide wire damage.Based upon the information provided and because only the guidewire was returned, the probable cause of this complaint could not be determined.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: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5335652
• MDR Text Key: 34759163
• Report Number: 3006425876-2015-00391
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: CV-22703
• Device Lot Number: 71F15D0935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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