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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 100/391/118CZ
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Death (1802); Pain (1994); Paresis (1998)
Event Date 04/05/2018
Event Type  Death  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information was received indicating that upon removal of a smiths medical portex® epidural minipack, the catheter ruptured; leaving approximately 15cm of catheter inside the patient. It was reported that the catheter was being attempted to be removed 2-3cm due to motor and sensitive blockage of the contralateral side. Exploration was necessary superficially but the distal end of the catheter was not noted. Neurosurgery was then consulted and intravenous analgesia was continued. There was no further adverse effects reported.
 
Event Description
Additional patient information was received that the patient has died. The customer stated that the death was not device related. No further information was provided.
 
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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 CZECH REPUBLIC A. S.
olomouck? 306
hranice 1-mesto,
EZ
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key7848691
MDR Text Key119322770
Report Number3012307300-2018-03584
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number100/391/118CZ
Device Lot Number3528085
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
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