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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 18G EPIDURAL MINIPACK SYSTEM 1 WITH PRE-ATTACHED TUOHY WING ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. 18G EPIDURAL MINIPACK SYSTEM 1 WITH PRE-ATTACHED TUOHY WING ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 915/018/0001JP
Device Problems Disconnection (1171); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The epifuse connector was returned in used condition. A visual inspection of the sample revealed no abnormality such as breakage. When unlocking the epifuse connector, the catheter was reconnected to the epifuse connector and the catheter removal test was performed. The reported event was not confirmed. This event seems to have occurred due to the fact that the catheter was not inserted deep enough in the epifuse connector / sleeve. A conclusive root cause could not be determined however.
 
Event Description
It was reported that the catheter slipped off from the connector while the patient was being transported. No death or serious injury was reported in connection with this incident.
 
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Brand Name18G EPIDURAL MINIPACK SYSTEM 1 WITH PRE-ATTACHED TUOHY WING
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7848868
MDR Text Key119329901
Report Number3012307300-2018-04153
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number915/018/0001JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

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