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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Device expiration date: unknown. Device manufacture date: unknown. 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 when using a bd phaseal¿ injector luer lock n35 there was coring when using the drug carfilzomib. Core was isolated to the vile, but medication had to be reconstituted.
 
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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
8015652341
MDR Report Key8367338
MDR Text Key137561407
Report Number3003152976-2019-00178
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeCA
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 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515003
Device Lot NumberUNKNOWN
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 Received02/05/2019
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

Patient Treatment Data
Date Received: 02/25/2019 Patient Sequence Number: 1
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