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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR

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BECTON, DICKINSON AND COMPANY BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 367342
Device Problem Retraction Problem (1536)
Patient Problem Insufficient Information (4580)
Event Date 09/17/2020
Event Type  malfunction  
Event Description
Phleb completed draw and safety device malfunctioned and did not completely retract the needle.
 
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Brand NameBD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key10566115
MDR Text Key207921974
Report Number10566115
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number367342
Device Catalogue Number367342
Device Lot Number0125355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/21/2020
Event Location Hospital
Date Report to Manufacturer09/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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