MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW THORACENTESIS KIT; CATHETER AND TIP, SUCTION

Catalog Number AK-01000

Device Problems Fitting Problem (2183); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that during a procedure there was a problem with one of the luer block connectors on the drainage tubing.The luer connector is partially squashed and won't fit into the aspirating syringe.The procedure took much longer to perform.No report of patient injury or consequence.

Manufacturer Narrative

(b)(4), upon initial triage of the returned sample, it was found that the malfunction was non-reportable; thus the initial mdr, submitted on 04/03/2017, was sent in error.

Event Description

The customer alleges that during a procedure there was a problem with one of the luer block connectors on the drainage tubing.The luer connector is partially squashed and won't fit into the aspirating syringe.The procedure took much longer to perform.No report of patient injury or consequence.

• Brand Name: ARROW THORACENTESIS KIT
• Type of Device: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6453978
• MDR Text Key: 71531132
• Report Number: 3003737899-2017-00029
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

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: 06/30/2018
• Device Catalogue Number: AK-01000
• Device Lot Number: 13F16L0141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• 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