MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14502

Device Problem Complete Blockage (1094)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

"patient who during the physical examination, the arterial line is blocked so there is no solution step, it is removed due to dysfunction".

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: "patient who during the physical examination, the arterial line is blocked so there is no solution step, it is removed due to dysfunction".

• Brand Name: ARROW CVC SET: 2-LUMEN 5 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8289823
• MDR Text Key: 134500599
• Report Number: 1036844-2019-00113
• 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: 12/11/2018

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: 07/31/2022
• Device Catalogue Number: CS-14502
• Device Lot Number: 23F17G0555
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1