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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD PHASEAL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

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BD BD PHASEAL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Model Number 515003
Device Problem Failure to Advance (2524)
Patient Problem No Information (3190)
Event Date 08/10/2017
Event Type  malfunction  
Event Description
Unable to slide the injector into the connector. Second injector obtained and worked fine.
 
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Brand NameBD PHASEAL
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
BD
5859 farinon dr
ste 200
san antonio TX 78249
MDR Report Key6886334
MDR Text Key87019184
Report Number6886334
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 08/21/2017,08/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number515003
Device Catalogue Number515003
Device Lot Number1702108
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2017
Event Location Hospital
Date Report to Manufacturer08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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