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

Catalog Number CV-26702-E

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

"patient with mixed respiratory failure requiring central vascular access, it was not possible to insert a peripherally inserted central catheter, so the right subclavian bilumen catheter was inserted, which presented damage to the guidewire when inserting the appropriate vein (it was fracture in multiple sites), which generates inability to dilate (dilator deformity) without allowing advancement of the central catheter, thus requiring the opening of a second bilumen catheter. " there was no patient injury or complication.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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
• MDR Report Key: 12729565
• MDR Text Key: 279346899
• Report Number: 3006425876-2021-01014
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F21D2221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial