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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO. BD VACUTAINER® SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367929
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Bd received samples and photos from the customer facility for investigation. The samples and photos were evaluated and the customer¿s indicated failure mode with the incident lot was observed. Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.
 
Event Description
It was reported that the bd vacutainer® sodium fluoride 3. 0mg n2e 6. 0mg plus blood collection tubes had stopper creep out or loose closure caused no serious injury medical intervention.
 
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Brand NameBD VACUTAINER® SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES
Type of DeviceBLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7532065
MDR Text Key108985297
Report Number1917413-2018-02441
Device Sequence Number1
Product Code OFZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367929
Device Lot Number7016715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? Yes
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: 05/22/2018 Patient Sequence Number: 1
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