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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515105
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Information (3190)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that during use of the bd phaseal¿ protector p50 there was an issue with flow.
 
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Brand NameBD PHASEAL¿ PROTECTOR P50
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 Key8124198
MDR Text Key129469227
Report Number3003152976-2018-00519
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K123213
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 Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number515105
Device Lot Number1506009
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 Manufactured06/22/2015
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: 12/03/2018 Patient Sequence Number: 1
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