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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE LYMPHOCYTE SEPARATION MEDIUM

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BECTON, DICKINSON & CO. BD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE LYMPHOCYTE SEPARATION MEDIUM Back to Search Results
Catalog Number 362753
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2018
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 the bd vacutainer® glass cpt molecular diagnostics tube had gel separation issues. There was no report of exposure, injury, or medical intervention.
 
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Brand NameBD VACUTAINER® GLASS CPT MOLECULAR DIAGNOSTICS TUBE
Type of DeviceLYMPHOCYTE SEPARATION MEDIUM
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 Key7965491
MDR Text Key123817717
Report Number1917413-2018-03583
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2019
Device Catalogue Number362753
Device Lot Number8059570
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 Received09/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2018
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: 10/15/2018 Patient Sequence Number: 1
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