MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8"; CATHETER, PERCUTANEOUS

Catalog Number CS-04301-EJ

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges the catheter migrated out from the patient.The catheter had been sutured and fixed with a dressing.

Manufacturer Narrative

(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing the catheter in use.The image shows the catheter migrated outside of the insertion site.The catheter in the image is sutured to the patient by the box clamp but not by the catheter suture wings.There is no visual evidence on the patient to indicate the catheter suture wings were used to secure the catheter.A device history record review was performed on the catheter and box clamp and no manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit states to "secure catheter to patient.Use integral side wings as primary suture site.In kits where provided, the catheter clamp and fastener should be utilized as a secondary suture site as necessary." the image supplied by the customer shows the catheter only sutured by the box clamp (secondary site) and not by the catheter suture wings (primary site), therefore the ifu was not followed which likely caused the catheter migration.The report that the catheter migrated was confirmed through examination of the customer supplied photo.The image showed the catheter migrated outside of the insertion site; however, the actual complaint sample was not returned for evaluation.The device history records for the catheter were reviewed with no evidence to suggest a manufacturing related cause.The ifu supplied with this kit explicitly instructs the user to use the catheter side wings as the primary suture site and the catheter clamp and fastener as a secondary suture site as necessary.The image supplied by the customer shows the catheter only sutured by the box clamp (secondary site) and not by the catheter suture wings (primary site); therefore the ifu was not followed which likely caused the catheter migration.Based on the customer supplied image, user error caused or contributed to this event.An in-service request was initiated to follow up with the customer on proper use according to the ifu.

Event Description

The customer alleges the catheter migrated out from the patient.The catheter had been sutured and fixed with a dressing.

• Brand Name: ARROW CVC SET: 16 GA X 8"
• 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: 7100543
• MDR Text Key: 94281780
• Report Number: 3006425876-2017-00559
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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: 02/16/2022
• Device Catalogue Number: CS-04301-EJ
• Device Lot Number: 71F17B1114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• 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: 89 YR