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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 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
Additional lot number: 9256425; additional expiration date: 2019-09-13. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Additional manufacture date: 2020-09-30.
 
Event Description
It was reported that a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2. 0ml had poor barrier separation after centrifugation. The following information was provided by the initial reporter: "the costumer complained that sometimes after centrifugation , separation doesn¿t occur at all and the gel just come down only after second centrifugation the separation occurred and even then not always they get concentrated mononuclear cells layer but dispersed layer. In other cases after one centrifugation the mononuclear cells layer comes out dispersed".
 
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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 Key9683347
MDR Text Key189176093
Report Number1917413-2020-00086
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeIS
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2020
Device Catalogue Number362780
Device Lot Number9087924
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 Received01/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2019
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: 02/07/2020 Patient Sequence Number: 1
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