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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA TRAY CONTINUOUS EPIDURAL
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ANESTHESIA TRAY CONTINUOUS EPIDURAL Back to Search Results
Catalog Number 401386
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the anesthesia tray continuous epidural experienced leakage.The following information was provided by the initial reporter: defect in the filter of the epidural catheter, the filter showed a leak at the time of the medication infusion.
 
Event Description
It was reported that the anesthesia tray continuous epidural experienced leakage.The following information was provided by the initial reporter: defect in the filter of the epidural catheter, the filter showed a leak at the time of the medication infusion.
 
Manufacturer Narrative
H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.See h.10.
 
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Brand Name
ANESTHESIA TRAY CONTINUOUS EPIDURAL
Type of Device
ANESTHESIA TRAY
MDR Report Key11033195
MDR Text Key241258521
Report Number9610048-2020-00179
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number401386
Device Lot Number9301317
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2021
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
Patient Sequence Number1
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