MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIDURAL MINIPACK; ANESTHESIA CONDUCTION KIT

Catalog Number 100/391/118CZ

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2017

Event Type  malfunction  

Event Description

It was reported that after using a portex® epidural minipack, the connector was found to be "faulty" and leaking.Another kit was opened and the connector from that kit was used.No injury was reported.

Manufacturer Narrative

One epidural flat filter, 10ml syringe, blue plastic luer slip, tuohy needle, and the complaint device were returned for evaluation.Visual inspection found the complaint device in good condition.Functional testing involved a leak test and found that leakage was observed from the complaint device.Microscopic inspection found that the source of the leak was at a tear in the rubber part of the device.Based on the evidence, the complaint was observed and a root cause was unable to be confirmed.

• Brand Name: PORTEX® EPIDURAL MINIPACK
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A. S.; olomoucká 306; hranice 1 - mesto; hranice, 753 0 1; EZ 753 01
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7121290
• MDR Text Key: 95072343
• Report Number: 3012307300-2017-02608
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/10/2022
• Device Catalogue Number: 100/391/118CZ
• Device Lot Number: 3350604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1