MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 4- LUMEN 8.5FR X 16CM; ADULT MULTI-LUMEN CATHETER PRODUCTS

Catalog Number CV-12854

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2014

Event Type  malfunction  

Event Description

It was reported that "while purging, there was no reflux in the blue lumen 18g of the catheter because it was occluded (it was impossible to reintroduce the mandrin guide as there was a blockage) an extension line with 4 lumen was then put in place on one of the remaining lumen but the results were unsatisfactory.Incident occurred in the cardiology unit.Insertion site of the catheter: radial artery no consequences on the patient - he is fine.

Manufacturer Narrative

(b)(4).

• Brand Name: CVC SET: 4- LUMEN 8.5FR X 16CM
• Type of Device: ADULT MULTI-LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 2359/47; zdar nad sazavou 591 01; EZ 591 01
• Manufacturer Contact: alice harper ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4239647
• MDR Text Key: 5014263
• Report Number: 3006425876-2014-00213
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: CV-12854
• Device Lot Number: 71F14E1166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1