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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA KIT DURASAFE 18X3-1/2; ANESTHESIA CONDUCTION KIT

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ANESTHESIA KIT DURASAFE 18X3-1/2; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 400714
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2020
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 kit durasafe 18x3-1/2 experienced leakage prior to use.The following information was provided by the initial reporter: product presents spill.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 9176684 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To further investigate this issue, one picture sample was provided for evaluation by our quality engineer team.The picture sample displayed signs of leakage within the product packaging.As our quality team handles the final packaging only for this product, a notification has been sent to the supplier of the related kit components that may have contributed to the observed leakage.At this time, a definite cause for the issue has not been determined.Our quality team will continue to monitor the production process for signs of this potential defect.H3 other text : see h.10.
 
Event Description
It was reported that the anesthesia kit durasafe 18x3-1/2 experienced leakage prior to use.The following information was provided by the initial reporter: product presents spill.
 
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Brand Name
ANESTHESIA KIT DURASAFE 18X3-1/2
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key9759359
MDR Text Key191670955
Report Number9610847-2020-00062
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/01/2021
Device Catalogue Number400714
Device Lot Number9176684
Initial Date Manufacturer Received 02/06/2020
Initial Date FDA Received02/26/2020
Supplement Dates Manufacturer Received02/06/2020
Supplement Dates FDA Received02/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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