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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER®; UNKNOWN

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BECTON DICKINSON BD VACUTAINER®; UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2015
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Medical device brand name: unknown.Medical device type: unknown.Common device name: unknown.Unknown manufacturer: 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.Therefore, bd corporate headquarters in (b)(4).Medical device catalog#: unknown.Medical device lot#: unknown.Medical device expiration date: unknown.Unique identifier (udi) #: unknown.Device manufacture date: unknown.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
 
Event Description
It was reported that an unknown device had poor barrier separation.
 
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Brand Name
BD VACUTAINER®
Type of Device
UNKNOWN
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 Key7514681
MDR Text Key108498331
Report Number2243072-2018-00673
Device Sequence Number1
Product Code FMH
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 Other
Type of Report Initial
Report Date 05/01/2018
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 Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/09/2015
Initial Date FDA Received05/15/2018
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
Patient Sequence Number1
Patient Outcome(s) Other;
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