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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA TRAY CONTINUOUS EPIDURAL; ANESTHESIA CONDUCTION KIT
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ANESTHESIA TRAY CONTINUOUS EPIDURAL; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401386
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
Event Type  malfunction  
Manufacturer Narrative
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 the anesthesia tray continuous epidural syringe tip was broken.The following information was provided by the initial reporter, translated from portuguese to english: "glass syringe that comes inside the kit has a broken tip.".
 
Manufacturer Narrative
H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0119718, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the glass syringe was broken.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for investigation a definitive root cause could not be determined.
 
Event Description
It was reported that the anesthesia tray continuous epidural syringe tip was broken.The following information was provided by the initial reporter, translated from portuguese to english: "glass syringe that comes inside the kit has a broken tip.".
 
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Brand Name
ANESTHESIA TRAY CONTINUOUS EPIDURAL
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key11868012
MDR Text Key252177602
Report Number9610048-2021-00081
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 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2022
Device Catalogue Number401386
Device Lot Number0119718
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2020
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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