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

Model Number IPN030899

Device Problems Complete Blockage (1094); Material Twisted/Bent (2981)

Patient Problem Death (1802)

Event Date 06/04/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: involving a covid-19 female patient that was in resuscitation department prior to the incident. During use, the distal catheter extension line twisted in/fold on itself. The infusion could not go through because of this issue so the doctor untwisted / unfold the extension line to make the infusion flow again. No medical intervention was necessary. The patient is deceased , but the customer clearly stated on the phone that the device did not contribute to the event because patient died from covid-19 few hours later.

Manufacturer Narrative

(b)(4). The customer returned one 2-lumen cvc for evaluation. The catheter body contained slight signs of use in the form of biological material. Visual examination of the catheter did not reveal any defects or anomalies. The extension lines did not contain creases or bends. The total length of the catheter body measured to be 215 mm which is within specifications of 207-227 mm per product drawing. The catheter was flushed using a water-filled lab inventory syringe. No leaks or blockages were detected. A lab inventory guide wire was able to pass through the returned catheter with minimal resistance. A device history record review was performed on the lot number reported (71f19k2279) with no relevant findings. The instructions-for-use provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow. Secure only at indicated stabilization locations. " the customer report of blocked/kinked extension lines could not be confirmed by complaint investigation of the returned sample. The sample passed all relevant visual, dimensional, and functional testing. A device history record review was performed with no relevant findings. No problem was found with the returned sample. Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: involving a covid - 19 female patient that was in resuscitation department prior to the incident. During use, the distal catheter extension line twisted in/fold on itself. The infusion could not go through because of this issue so the doctor untwisted / unfold the extension line to make the infusion flow again. No medical intervention was necessary. The patient is deceased, but the customer clearly stated on the phone that the device did not contribute to the event because patient died from covid - 19 few hours later. Several attempts were made to gather additional information from the customer; however, the customer has not responded.

• 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
• 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: 10158236
• MDR Text Key: 195264827
• Report Number: 3006425876-2020-00521
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/16/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: IPN030899
• Device Catalogue Number: CV-16702
• Device LOT Number: 71F19K2279
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/16/2020 Patient Sequence Number: 1