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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ NH: 132 USP UNITS FICOLL¿: 2.0ML EVACUATED BLOOD COLLECTION TUBE IVD

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BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ NH: 132 USP UNITS FICOLL¿: 2.0ML EVACUATED BLOOD COLLECTION TUBE IVD Back to Search Results
Catalog Number 362753
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Code Available (3191)
Event Date 01/02/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. 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 a bd vacutainer® cpt¿ nh: 132 usp units ficoll¿: 2. 0ml produced erroneous results causing the patient to be redrawn.
 
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Brand NameBD VACUTAINER® CPT¿ NH: 132 USP UNITS FICOLL¿: 2.0ML
Type of DeviceEVACUATED BLOOD COLLECTION TUBE IVD
Manufacturer (Section D)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8257489
MDR Text Key133462739
Report Number1917413-2019-00007
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K891407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2019
Device Catalogue Number362753
Device Lot Number8213831
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 Received01/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
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: 01/17/2019 Patient Sequence Number: 1
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