MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT

Catalog Number JC-05400-B

Device Problem Fluid Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the plunger's syringe is leaking. Leak of sterile water. There was no patient injury.

Manufacturer Narrative

(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the lor syringe with no evidence to indicate a manufacturing related issue. Therefore, the potential cause of the syringe leaking could not be determined based upon the information provided and without the sample.

Event Description

It was reported that the plunger's syringe is leaking. Leak of sterile water. There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7757693
• MDR Text Key: 116378168
• Report Number: 3006425876-2018-00524
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/18/2020
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F18C1794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage