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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J CLOSED SYSTEM DRUG DELIVERY

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BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J CLOSED SYSTEM DRUG DELIVERY Back to Search Results
Catalog Number 515111
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
Event Type  malfunction  
Manufacturer Narrative
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 with the use of the bd phaseal¿ protector p50j there was an issue with malfunction. It was reported that ¿the bladder didn't inflate from the 2nd try. ¿ there was no report of injury or further medical intervention.
 
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Brand NameBD PHASEAL¿ PROTECTOR P50J
Type of DeviceCLOSED SYSTEM DRUG DELIVERY
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 Key7749188
MDR Text Key116270292
Report Number3003152976-2018-00348
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515111
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Was Device Evaluated by Manufacturer? Yes
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: 08/03/2018 Patient Sequence Number: 1
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