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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND COMPANY BD VACUTAINER ULTRA TOUCH PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 367365
Device Problems Break (1069); Retraction Problem (1536); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 09/19/2020
Event Type  malfunction  
Event Description
After lab sample was obtained, rn pressed the safety release button on the vacutainer collection set and the needle did not retract back into the collection set. The needle instead broke loose and rolled off of the patients arm onto the table next to her. Neither nurse nor pt was harmed. Rn had to pick up used needle and place into the red bin.
 
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Brand NameBD VACUTAINER ULTRA TOUCH 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 Key10725910
MDR Text Key212744173
Report Number10725910
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 10/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number367365
Device Catalogue Number367365
Device Lot Number9316398
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2020
Event Location Hospital
Date Report to Manufacturer10/23/2020
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? No
Type of Device Usage Unkown

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