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

Catalog Number EPK4000/118CJP

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  malfunction  

Event Description

Information was received indicating that following insertion of the catheter to a smiths medical portex® epidural minipack, it was attempted to be flushed using saline. Leakage was then observed at the syringe - filter intersection. The product was discontinued with no reported adverse effects.

Manufacturer Narrative

One portex® epidural minipack was returned in used condition. Visual inspection of the sample revealed a crack in the female connector of the flat filter. The customer's complaint of leakage was therefore confirmed.

• Brand Name: PORTEX® EPIDURAL MINIPACKS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL JAPAN LTD.,; komaki facilities; 627-1 yokouchi; komaki-shi, aichi 485-0081 ; JA
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 7740898
• MDR Text Key: 115771608
• Report Number: 3012307300-2018-02972
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: EPK4000/118CJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial