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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515070
Device Problem Disconnection (1171)
Patient Problem Insufficient Information (4580)
Event Date 12/05/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the bd phaseal¿ optima connector (c35-o) disconnected from the phaseal optima injector during the cytarabine infusion. The following information was provided by the initial reporter: "patient on december 5th vhad her optima injector disconnect during dinner from the needless connector attached to the picc line. Her lines were check prior to the incident happen but the patient even mentioned that this has never happened before. The patient was on a chemo protocol at the time with cytarabine infusion that morning and was suppose to start bite the following day. At the time of the event she only had fluids running and denied any activity to cause the event to happen. ".
 
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Brand NameBD PHASEAL¿ OPTIMA CONNECTOR (C35-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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14155033
MDR Text Key289758394
Report Number3003152976-2022-00158
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515070
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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