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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIFUSE® EPIDURAL CATHETER CONNECTOR ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX® EPIFUSE® EPIDURAL CATHETER CONNECTOR ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EPX1308/118JP
Device Problems Fluid Leak (1250); Material Integrity Problem (2978)
Patient Problems Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199)
Event Date 05/02/2018
Event Type  Injury  
Event Description
Information was received indicating that after two days of use this epidural catheter connector exhibited leakage. It was noted that there was damage to the hinge part of the connector. No adverse patient effects were reported.
 
Manufacturer Narrative
One epifuse connector was returned. The customer's reported problem was "two days after start of use, leakage occurred from the connector part. The customer confirmed damage of the hinge part on the epifuse connector". As a result of observing the sample, it was confirmed that the hinge part was broken into two parts. Cracks cannot be detected in the epifuse connector without bending the hinge part. The manufacturing and quality inspection processes were reviewed and considered adequate and correct. The root cause and timing of occurrence was not identified.
 
Manufacturer Narrative
Medical intervention included ett, mechanical ventilation with peep of 20, and vasopressor bp support.
 
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Brand NamePORTEX® EPIFUSE® EPIDURAL CATHETER CONNECTOR
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7550339
MDR Text Key109496495
Report Number3012307300-2018-01992
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 company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEPX1308/118JP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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