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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT
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BD (SUZHOU) BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401622
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9319727, medical device expiration date: 2024-11-10, device manufacture date: 2019-11-15. Medical device lot #: 9319733, medical device expiration date: 2024-11-22, device manufacture date: 2019-11-15. 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 outer box of bd durasafe¿ trays had a modified batch number on it. This affected 10 trays from lot 9319727, and 11 trays from lot 9319733. The following information was provided by the initial reporter, translated from chinese to english: "when receiving the goods, their three-party warehouse found that the batch number on the outer box had been modified".
 
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Brand NameBD DURASAFE¿ TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key10860810
MDR Text Key226089096
Report Number3006948883-2020-00788
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 distributor,foreign,other
Type of Report Initial,Followup,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number401622
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2021
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

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