MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 16 CM CATHETER PERCUTANEOUS

Model Number IPN038301

Device Problems Device Contamination with Chemical or Other Material (2944); Suction Failure (4039)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4). It is unknown if the device sample is available for evaluation.

Event Description

It was reported that the central line and vascath both inserted into left jugular vein (lij) on (b)(6) 2020. Difficulty using the vascath noted on (b)(6) 2020 with continuous alarms of high pressures and unable to aspirate on one of the ports. Decision to insert new vascath into right internal jugular (rij). On checking the cxr following the new rij line insertion, an opacity was noted distal to the old lij vascath. On removing the old lij vascath the user cut the distal end of the vascath, to discover one port was filled with white plastic looking material. Delay in treatment to due new insertion of cvc.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 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: 10158367
• MDR Text Key: 195265950
• Report Number: 3006425876-2020-00527
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/05/2020

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: IPN038301
• Device Catalogue Number: CS-12123-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial