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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515064
Device Problems Inflation Problem (1310); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2019
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 that the expansion chamber on a bd phaseal optima protector (p20-o) did not inflate and a spray droplets appeared on the outside of the vial.
 
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Brand NameBD PHASEAL OPTIMA PROTECTOR (P20-O)
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
8015652341
MDR Report Key8367279
MDR Text Key137560262
Report Number3003152976-2019-00177
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K181221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2019
Device Catalogue Number515064
Device Lot Number1807701
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 Received02/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2018
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: 02/25/2019 Patient Sequence Number: 1
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