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

Catalog Number CV-17702-E

Device Problems Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the catheter was broken off by the patient.The hospital reports that the force was not that strong given by a (b)(6) year old patient.The edge of the incision was neat.

Manufacturer Narrative

Qn#(b)(4).The customer did not return a complaint sample; however, they supplied two photos showing a lidstock and a used cvc catheter.The catheter body appeared to be separated approximately 2" from the juncture hub but it cannot be determined without the sample to evaluate.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow".The report that the catheter body was cut/torn during use was confirmed through examination of the customer supplied photos.The image showed the catheter body severed approximately two inches from the juncture hub; however, the actual complaint sample was not returned for analysis.The device history record review did not reveal any relevant findings to suggest a manufacturing related cause.The probable cause of this complaint issue could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the catheter was broken off by the patient.The hospital reports that the force was not that strong given by a 70 year old patient.The edge of the incision was neat.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9266480
• MDR Text Key: 167016344
• Report Number: 3006425876-2019-00883
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/11/2022
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F17A0901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR