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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD; INC. PORTEX® EPIDURAL MINIPACKS ANESTHESIA CONDUCTION KIT Back to Search Results
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.
 
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Brand NamePORTEX® EPIDURAL MINIPACKS
Type of DeviceANESTHESIA 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 Key7740898
MDR Text Key115771608
Report Number3012307300-2018-02972
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,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEPK4000/118CJP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2018
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

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