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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 Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8152656 medical device expiration date: 2019-06-30 device manufacture date: 2018-06-01 medical device lot #: 8134751 medical device expiration date: 2019-05-31 device manufacture date: 2018-05-14. 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 during use of the bd vacutainer® glass cpt molecular diagnostics tube the blood sample is not separating.
 
Event Description
It was reported that during use of the bd vacutainer glass cpt molecular diagnostics tube the blood sample is not separating.
 
Manufacturer Narrative
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. 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. The investigation is still on-going and improvements will be made as the potential causes of this issue are identified. As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd. However, further investigation has been initiated through a capa. The investigation is still on-going and improvements will be made as the potential causes are identified. Although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s). 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 and implement corrective actions. The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.
 
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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
MDR Report Key8101702
MDR Text Key128444377
Report Number1917413-2018-03829
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number362753
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/26/2018 Patient Sequence Number: 1
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