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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER NO ADDITIVE (Z) TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER

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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER NO ADDITIVE (Z) TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Model Number 366703
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2021
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® no additive (z) tube there was foreign matter in the tube(s) biological and non-biological. This event occurred 4 times. The following information was provided by the initial reporter. The customer stated: "four unused vacutainers were found to have a non biological black dot inside of them. Black specs on sample tubes. Prior to processing plasma bottle, sample tubes unsuitable. ".
 
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Brand NameBD VACUTAINER NO ADDITIVE (Z) TUBES
Type of DeviceSPECIMEN TRANSPORT AND STORAGE CONTAINER
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 Key11898261
MDR Text Key266922424
Report Number1917413-2021-00451
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2021
Device Model Number366703
Device Catalogue Number366703
Device Lot Number9280861
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 Received06/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
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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