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

Catalog Number EPX1305/118DJP

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Please see mfr #: 3012307300-2018-03167 for related device incident earlier the same day.The evaluation summary below is applicable to both reported events.Evaluation summary: one epifuse connector, flat filter, epidural catheter and filter cover were returned for analysis but the lot number was unavailable.The customer's reported issue regarding leaking fluid was confirmed by simulated use testing.When the epifuse connector was unlocked and water was injected, water leakage from the sleeve of the epifuse connector was confirmed.Water leakage appeared to occur due to cracks caused by supplier-purchased components (sharp blades, etc.) contacting the sleeve surface of the epifuse connector, but the exact cause and the timing of occurrence could not be identified.Although this event is considered to be a rare case occurring accidentally, we report to the manufacturer about the occurrence of this event and record it in the domestic overseas database and monitor the occurrence trend in the future.

Event Description

It was reported that medical fluid leaked from the filter connection site of an epidural catheter connector.The fault occured while in use with a patient but there was no patient injury associated with this incident.This report is documenting a second leak occurence that happened later in the day.

• Brand Name: PORTEX® CUSTOM CONTINUOUS EPIDURAL TRAY
• 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 JAPAN LTD.; komaki facilities; 627-1 yokouchi; komaki-shi, aichi 485-0 081; JA 485-0081
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7722588
• MDR Text Key: 115191344
• Report Number: 3012307300-2018-03167
• 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: Other
• Type of Report: Initial
• Report Date: 07/26/2018

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 Catalogue Number: EPX1305/118DJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/26/2018
• 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
• Patient Sequence Number: 1