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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLUS TUBES, WITH CLEAR BD HEMOGARD¿ CLOSURE SERUM TUBE

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BECTON, DICKINSON & CO. BD VACUTAINER® PLUS TUBES, WITH CLEAR BD HEMOGARD¿ CLOSURE SERUM TUBE Back to Search Results
Catalog Number 366703
Device Problems Break (1069); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2015
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. A review of the manufacturing records was completed for the incident lot and no issues were identified. Conclusion: unconfirmed complaint. This product has no instructions, guarantees, specifications or qualifications for use regarding freezing and thawing of tubes.
 
Event Description
It was reported that multiple bd vacutainer® plus tubes (13x75mm, 3 ml) , with the clear bd hemogard¿ closure, are beaking during freezing of sample tubes. No serious injury, blood to mucous membrane exposure or medical intervention was reported.
 
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Brand NameBD VACUTAINER® PLUS TUBES, WITH CLEAR BD HEMOGARD¿ CLOSURE
Type of DeviceSERUM TUBE
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 Key7081346
MDR Text Key93906342
Report Number1917413-2017-00192
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2016
Device Catalogue Number366703
Device Lot Number5089721
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2015
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: 12/04/2017 Patient Sequence Number: 1
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