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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515003
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 that a bd phaseal¿ injector luer lock n35 had resistance and the plunger of the syringe moved back.
 
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Brand NameBD PHASEAL¿ INJECTOR LUER LOCK N35
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8121311
MDR Text Key129458584
Report Number3003152976-2018-00521
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K140591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2018
Device Catalogue Number515003
Device Lot Number1607005
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/30/2018 Patient Sequence Number: 1
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