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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 Consequences Or Impact To Patient (2199)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone #: (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that while using bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2. 0ml there was poor sample quality and there is a loss of cells able to be recovered. There was no reported patient impact. The following information was provided by the initial reporter, translated from (b)(6) to english: experienced user of bd cpt tubes for several different studies, using the same protocol successfully - only with the recently started study with blood collection and pmbc isolation from samples from covid-19 patients, they don´t revover the cell numbers they are used to (approximately 10 million cells) after the first washing step. Same conditions, protocol, centrifuges like in other studies. It is not 100% clear whether they loose the cells during the washing step or whether they don´t harvest the cells from the cpt in the step before. Not clear whether it is a patient specific factor causing this, as cpt performance in the other studies is satisfactory. Hematology analysis of the blood of the covid-19 patients in the study is normal, cell numbers normal. When the pbmcs are isolated from samples from covid-19 patients, the yield is only about 10% of the expected yield.
 
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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
8015296192
MDR Report Key11090938
MDR Text Key225337342
Report Number1917413-2020-01264
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeAU
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 02/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Catalogue Number362780
Device Lot Number0232798
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 Received02/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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