MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CS-22855

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported that "the lumnia moves to easily, with the effect of closing off.".

Manufacturer Narrative

Qn#(b)(4).The customer has provided additional information indicating the initial report of the product code was incorrect.They have provided the correct product code and it is for a product that is not sold in the us; thus, the initial report that was submitted on 02/03/2020 was submitted in error.

Event Description

Customer reported that "the lumnia moves to easily, with the effect of closing off.".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9659809
• MDR Text Key: 177406563
• Report Number: 3006425876-2020-00106
• 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: 01/20/2020

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: Health Professional
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: CS-22855
• Device Lot Number: 71F19K2910
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1