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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:

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Device Problems Loose or Intermittent Connection (1371); Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical epidural was disconnected at the filter attachment with the filter no longer attached to the patient side and the result that epidural infusion stopped. It was removed and alternative post-op analgesia provided. No adverse events reported.
 
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MDR Report Key12122648
MDR Text Key262546292
Report Number3012307300-2021-06836
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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