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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD VACUTAINERS AND BLOOD CULTURE BOTTLES; CONTAINER, SPECIMEN, STERILE
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BECTON DICKINSON AND COMPANY BD VACUTAINERS AND BLOOD CULTURE BOTTLES; CONTAINER, SPECIMEN, STERILE Back to Search Results
Lot Number 0066004
Device Problem Filling Problem (1233)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2020
Event Type  malfunction  
Event Description
Phlebotomist doing morning rounds went to collect orders on patient.The first specimen collection tube for coagulation studies only filled half way which is unacceptable for testing.Phlebotomist put on a new tube and the same problem happened.It happened again when she put on the third tube.The patient then told her she had done a good job, but asked to wait and have the collection tried again later.Phlebotomist then reported the problem to her supervisor.A query has been submitted to the vendor.All lab process followed.This has apparently occurred on multiple patients with various vacutainers.I have a picture of one package from which a vacutainer was.Fda safety report id: (b)(4).
 
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Brand Name
BD VACUTAINERS AND BLOOD CULTURE BOTTLES
Type of Device
CONTAINER, SPECIMEN, STERILE
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key10188835
MDR Text Key196412741
Report NumberMW5095161
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/19/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Lot Number0066004
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age86 YR
Patient Weight83
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