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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 362780
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
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 when using the bd vacutainer® cpt¿ mononuclear cell preparation tube there was poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: there was "no proper separation of blood sample in cpt.After centrifuge, there was blood above the plasma and during the mixing of the tubes it was mixed with the spun plasm.".
 
Manufacturer Narrative
H6: investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, the indicated failure mode for poor barrier separation was not observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was not able to confirm the customer¿s indicated failure (poor separation, red cells above the separator) because the defect was not evident in the returned lot samples.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode poor barrier separation based on photos only.Bd was not able to identify a root cause for the indicated failure mode.
 
Event Description
It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube there was poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: there was "no proper separation of blood sample in cpt.After centrifuge, there was blood above the plasma and during the mixing of the tubes it was mixed with the spun plasm.".
 
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Brand Name
BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE
Type of Device
BLOOD 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12854227
MDR Text Key281103561
Report Number1917413-2021-01002
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Catalogue Number362780
Device Lot Number1175891
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2021
Initial Date FDA Received11/22/2021
Supplement Dates Manufacturer Received12/08/2021
Supplement Dates FDA Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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