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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. PORTEX® CUSTOM CONTINUOUS EPIDURAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EPX1305/118DJP
Device Problem Fluid 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.
 
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Brand NamePORTEX® CUSTOM CONTINUOUS EPIDURAL TRAY
Type of DeviceANESTHESIA 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 Key7722588
MDR Text Key115191344
Report Number3012307300-2018-03167
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEPX1305/118DJP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
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

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