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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE CELL PREP TUBE

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BECTON, DICKINSON & CO. BD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE CELL PREP TUBE Back to Search Results
Catalog Number 362753
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2016
Event Type  malfunction  
Manufacturer Narrative
Date received by manufacturer was reported incorrectly. The correct date received by manufacturer is 12/21/2016.
 
Manufacturer Narrative
Correction: medical device type changed to jcf.
 
Manufacturer Narrative
Results: bd received samples and photos from the customer facility for investigation. The samples and photos were evaluated and the customer¿s indicated failure mode for breakage with the incident lot was not observed. Additionally, a review of the manufacturing records was completed for the incident lot #6119586 and no issues were identified. Conclusion: an absolute root cause for this incident cannot be determined.
 
Event Description
It was reported that 16x125 mm. , 8. 0 ml. Bd vacutainer® cpt glass molecular diagnostics tube. Green/red conventional closure. See thru label. Additive: density gradient polymer gel and sodium heparin for mononuclear cell preparation, broke during centrifugation. No injury or medical intervention.
 
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Brand NameBD VACUTAINER® CPT GLASS MOLECULAR DIAGNOSTICS TUBE
Type of DeviceCELL PREP 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 Key7084403
MDR Text Key253176623
Report Number1917413-2017-00434
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2017
Device Catalogue Number362753
Device Lot Number6119586
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2016
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: 12/05/2017 Patient Sequence Number: 1
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