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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD CONTINUOUS EPIDURAL TRAY
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CAREFUSION, INC BD CONTINUOUS EPIDURAL TRAY Back to Search Results
Catalog Number 400840
Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a 18gx3.5 weiss 20g ce,5ml lor ll,27g hyp had a difficult epidural connector.The following was reported, "material no.: 400840.Batch/lot: unknown/ not provided.It was reported that "providers are having issues with the epidural connector - it¿s difficult to put on the epidural line to the point where it¿s been falling off the line and issues of the provider tightening it too much which has been constricting the line not allowing the medicine to go through the line.".
 
Event Description
It was reported that a 18gx3.5 weiss 20g ce,5ml lor ll,27g hyp had a difficult epidural connector.The following was reported, "material no.: 400840.Batch/lot: unknown/ not provided.It was reported that "providers are having issues with the epidural connector - it¿s difficult to put on the epidural line to the point where it¿s been falling off the line and issues of the provider tightening it too much which has been constricting the line not allowing the medicine to go through the line.".
 
Manufacturer Narrative
Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD CONTINUOUS EPIDURAL TRAY
Type of Device
EPIDURAL TRAY
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8493792
MDR Text Key141448374
Report Number1625685-2019-00020
Device Sequence Number0
Product Code CAZ
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
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 Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400840
Device Lot NumberUNKNOWN
Date Manufacturer Received03/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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