MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 4-LUMEN 8.5FR X 20CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number AG-15854-UN

Device Problems Kinked (1339); Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2015

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.Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.Device evaluation: the reported complaint of dilator damage found during preparation was confirmed through examination of a returned sample.The customer also returned a guide wire that was found to be kinked in three places near the distal and.Sink marks were observed in the dilator body and functional testing revealed the id of the dilator was blocked in the area of the sink mark.The guide wire could not pass through.The device history records were reviewed was performed on the dilator and guide wire with no findings relevant to this complaint.But, based on the block in the dilator and the presence of a sink mark on the outside of the dilator body, the probable cause of this complaint issue is manufacturing related.Further investigation has been initiated at the manufacturing site.

Event Description

It was reported that during preparation, it was noted that the tip of the dilator was found damaged/cracked.As a result, 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.

• Brand Name: CVC SET: 4-LUMEN 8.5FR X 20CM
• 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: 5348332
• MDR Text Key: 35212990
• Report Number: 3006425876-2016-00004
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K862056
• 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
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: AG-15854-UN
• Device Lot Number: 71F15F1052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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