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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the unspecified bd intravascular administration set was deformed/damaged/cracked. The following information was provided by the initial reporter: material #: unknown batch/ lot #: unknown. Cracked luer lock.
 
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Brand NameUNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11103400
MDR Text Key226318281
Report Number2243072-2020-02264
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received01/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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