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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANESTHESIA KIT DURASAFE 18X3-1/2 ANESTHESIA CONDUCTION KIT

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANESTHESIA KIT DURASAFE 18X3-1/2 ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 400714
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that anesthesia kit durasafe 18x3-1/2 leaked. The following information was provided by the initial reporter: "product damaged, leak. ".
 
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Brand NameANESTHESIA KIT DURASAFE 18X3-1/2
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
MDR Report Key11926499
MDR Text Key262870705
Report Number9610847-2021-00249
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 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400714
Device Lot Number0345974
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2021
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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