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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE LYMPHOCYTE SEPARATION MEDIUM Back to Search Results
Catalog Number 362760
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd vacutainer® cpt¿ mononuclear cell preparation tube - sodium citrate exhibited poor barrier separation. No serious injury or medical intervention was reported.
 
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Brand NameBD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE
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 Key8016527
MDR Text Key125602723
Report Number1917413-2018-03666
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911731
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 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2019
Device Catalogue Number362760
Device Lot Number8059572
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2018
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: 10/29/2018 Patient Sequence Number: 1
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