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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA DRUG VIAL ACCESS DEVICE

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BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA DRUG VIAL ACCESS DEVICE Back to Search Results
Catalog Number 515052
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2018
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¿ optima there was an issue with injector difficult to engage. There was no report of injury or medical intervention.
 
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Brand NameBD PHASEAL¿ OPTIMA
Type of DeviceDRUG VIAL ACCESS DEVICE
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 Key7975039
MDR Text Key124335879
Report Number3003152976-2018-00447
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeCA
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2019
Device Catalogue Number515052
Device Lot Number1805701
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 Received09/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2018
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: 10/17/2018 Patient Sequence Number: 1
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