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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 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
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 180 bd vacutainers® cpt¿ nh: ~130 iu ficoll¿: 2. 0ml experienced poor separator movement which was noted after use. The following information was provided by the initial reporter: during a new study, the bd cpt tubes did not work as expected. Out of 30 tubes there was no gel movement at 30%, the whole blood was still above the gel after centrifugation. The yield was also lower than expected, 2-5 million leukocytes per tube. Centrifugation conditions were okay, 25min at 1800 rcf and 22°c (temperature controlled centrifuge). In the tubes where no separation had occurred, the supernatant was re-suspended and transferred to a second bd cpt tube. After renewed centrifugation, the separation of the pbmcs had also worked for these samples. The customer is an experienced user, in previous studies she may have had one or two tubes with this phenomenon, but never 30%.
 
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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 Key9933694
MDR Text Key187761258
Report Number1917413-2020-00368
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 distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2020
Device Catalogue Number362780
Device Lot Number9315088
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 Received03/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2019
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: 04/07/2020 Patient Sequence Number: 1
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