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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 362780
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 30 bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2. 0ml experienced hemolysis during use. The following information was provided by the initial reporter: cpt, isolated cells contaminated with erythrocytes and low vitality laboratory receives centrifuged cpt from participants of a clinical study; the cells collected above the gel are contaminated with erythrocytes, often the sample looks hemolytic before further processing; total number of cells is high, 20-30 million cells, but a large proportion of them are probably erythrocytes. The vitality of the cells is below 87% (study sponsor gives 90% as a minimum requirement). After freezing (with dmso, protocol dictated by study sponsor), the vitality is> 90% and the cell count is 7-8 million. Study sites centrifuge 17 min between 1650 rcf and 1800 rcf.
 
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Brand NameBD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
Type of DeviceBLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9273518
MDR Text Key191174352
Report Number1917413-2019-02304
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2019
Device Catalogue Number362780
Device Lot Number8059582
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 Received10/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/04/2019 Patient Sequence Number: 1
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