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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE LYMPHOCYTE SEPARATION MEDIUM

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BECTON, DICKINSON & CO. BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE LYMPHOCYTE SEPARATION MEDIUM Back to Search Results
Catalog Number 362753
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Information (3190)
Event Date 11/12/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the samples of bd vacutainer® glass cpt molecular diagnostics tubes did not separate.
 
Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode for poor barrier separation with the incident lot was not observed. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product. Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified. The investigation is still on-going and improvements will be made as the potential causes of this issue are identified. Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for poor barrier separation with the incident lot was not observed. Further investigation activities have been conducted through a capa and the most likely root cause has been identified. The investigation is still on-going and improvements will be made as the potential causes of this issue are identified. Root cause description: although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s). Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue. The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.
 
Event Description
It was reported that the samples of bd vacutainer® glass cpt molecular diagnostics tubes did not separate.
 
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Brand NameBD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE
Type of DeviceLYMPHOCYTE SEPARATION MEDIUM
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 Key8125075
MDR Text Key129060603
Report Number1917413-2018-03855
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2019
Device Catalogue Number362753
Device Lot Number8186650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2018
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: 12/03/2018 Patient Sequence Number: 1
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