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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SYRINGE

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BECTON DICKINSON UNSPECIFIED BD¿ SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problem Laceration(s) (1946)
Event Date 02/12/2018
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. (b)(4). Medical device expiration date: unknown. The initial reporter also notified the fda in march 2018, via medwatch # (b)(4). Device manufacture date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that while using a unspecified bd¿ syringe, the syringe broke in the user¿s hand and lacerated their finger. There was no report of medical intervention.
 
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Brand NameUNSPECIFIED BD¿ SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7412719
MDR Text Key105374706
Report Number2243072-2018-00177
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
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