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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P50J

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BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P50J Back to Search Results
Catalog Number 515111
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 12/09/2020
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. (b)(4).
 
Event Description
It was reported that 25 bd phaseal¿ protectors p50j experienced damaged or open unit packaging/seals where sterility was compromised. The following information was provided by the initial reporter: the customer (hospital) complains about damaged packaging.
 
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Brand NameBD PHASEAL PROTECTOR P50J
Type of DevicePHASEAL PROTECTOR
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
8015296192
MDR Report Key11132155
MDR Text Key227079939
Report Number3003152976-2021-00011
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
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 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515111
Device Lot Number2003151
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 Received01/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2020
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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