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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SHARPS CONTAINER
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BECTON DICKINSON UNSPECIFIED BD SHARPS CONTAINER Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that unspecified bd¿ sharps container lids were not working properly.This occurred on 3 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via email: that the containers would not lock in place because the tabs are missing on two of the containers and the third one still had a loop tab on it but was barely hanging on.
 
Manufacturer Narrative
Investigation summary no sample was returned for analysis.No pictures were provided indicating the product number or lot.Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis.A device history review could not be completed as no batch number was provided.Without a sample, or photograph with part and lot information the investigation was unable to confirm the failure mode nor identify a probable root cause.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.H3 other text : see h10.
 
Event Description
It was reported that unspecified bd¿ sharps container lids were not working properly.This occurred on 3 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via email: that the containers would not lock in place because the tabs are missing on two of the containers and the third one still had a loop tab on it but was barely hanging on.
 
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Brand Name
UNSPECIFIED BD SHARPS CONTAINER
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11103377
MDR Text Key226318376
Report Number2243072-2020-02263
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received02/05/2021
Supplement Dates FDA Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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