MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-15703-KR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges that although the catheter was secured to the patient by suturing the white and blue box clamp and fastener to the skin, the user found the catheter migrated.No patient injury or complication reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the catheter and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer alleges that although the catheter was secured to the patient by suturing the white and blue box clamp and fastener to the skin, the user found the catheter migrated.No patient injury or complication reported.

Manufacturer Narrative

(b)(4).The customer returned a used mcz-15703-004 catheter, a k-14703-013a catheter clamp, and a k-14703-007a catheter clamp fastener.The suture sites for each item were visually inspected.One of the suture points on the catheter clamp was oblong, indicating use.There were no signs of use on the juncture hub suture wings.The catheter body outer diameter was measured and found to be within specification.The catheter clamp fastener diameter and the catheter clamp inner diameter were also measured and found to be within specification.The clamp and the clamp fastener were reassembled.The largest pin gauge that would pass through the clamp assembly without resistance was 0.050".This indicates that the clamp would securely hold a catheter that has an outer diameter of 0.096".The box clamp was placed on the catheter and the catheter body was then tugged on either side.The catheter remained in place.A device history record (dhr) review was performed and no relevant findings were found.Other remarks: the customer states that the catheter migrated "even though the catheter was secured to the patient by suturing the white and blue box clamp and fastener together to the skin, the user found the catheter migration".During the visual inspection it was found that the suture wings on the catheter hub did not have any signs of use, confirming that only the clamp and fastener were used to secure the catheter.The product ifu was reviewed and it states that the catheter hub is the primary securement site while the catheter clamp and fastener are to be used as a secondary site.The probable cause of this issue was determined to be operational context, therefore no additional action shall be taken.

Event Description

The customer alleges that although the catheter was secured to the patient by suturing the white and blue box clamp and fastener to the skin, the user found the catheter migrated.No patient injury or complication reported.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6656548
• MDR Text Key: 78045842
• Report Number: 3006425876-2017-00198
• 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,Followup
• Report Date: 06/02/2017

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: 10/31/2018
• Device Catalogue Number: ASK-15703-KR
• Device Lot Number: 71F16L0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 08/01/2017
• Supplement Dates FDA Received: 07/25/2017; 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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