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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN LYMPHOCYTE SEPARATION MEDIUM

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BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN 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 01/02/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. 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 bd vacutainer® cpt¿ cell preparation tube with sodium heparin had erroneous results from a "10 fold decrease in yield" compared to the "tube processed with ficoll", resulting in a delay of treatment to the patient, who then had to be redrawn at a later, undisclosed date.
 
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Brand NameBD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
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 Key8257387
MDR Text Key133461548
Report Number1917413-2019-00005
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number362753
Device Lot Number8213831
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
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: 01/17/2019 Patient Sequence Number: 1
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