MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 7FR X 20CM; CATHETER PERCUTANEOUS

Catalog Number ASK-17702-KR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device product is not intended for sale in the us.Similar product sold in the us.

Event Description

The customer alleges that during use the inserted catheter easily migrated out from the patient.The catheter was replaced.

Manufacturer Narrative

(b)(4).It was reported that the cvc catheter migrated out of the patient while in use.The customer did not report whether or not the primary suture site (triangular suture hub) was used.Based on visual and functional evaluation of the sample received, the complaint cannot be confirmed.The catheter and suture sites showed no signs of damage or anomalies, the catheter remained secure in the catheter clamp when it was tugged and the components met dimensional specifications.A device history review was performed and did not reveal any manufacturing related issues.Based on the evaluation of the returned sample, there was no problem found.No further action will be taken.

Event Description

The customer alleges that during use the inserted catheter easily migrated out from the patient.The catheter was replaced.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: linda woodall ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9196942566
• MDR Report Key: 6771654
• MDR Text Key: 81961567
• Report Number: 3006425876-2017-00281
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/25/2017

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: No Information
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: ASK-17702-KR
• Device Lot Number: 71F16L2078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• 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