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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 02/21/2016
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Result: bd had not received samples, but photos were provided by the customer facility for investigation. The photos were evaluated and the customer's indicated failure mode for breakage with the incident lot was observed. A review of the manufacturing records was completed for the incident lot # 5105880 and no issues were identified. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
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 Key7058841
MDR Text Key93611299
Report Number1917413-2017-00355
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeKS
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
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number362753
Device Lot Number5105880
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 Received02/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2015
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: 11/27/2017 Patient Sequence Number: 1
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