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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 515056
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/14/2021
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 when using the bd phaseal¿ optima injector (n40-o) there was a loose or separation of the injector and mating component. The following information was provided by the initial reporter. The customer stated: "the patient was found covered in blood. Chunky chemo connector found to be loose connection to iv tubing with blood spilling out of central line. " additional customer response: "after further investigation, all of the items were still attached, but the tubing was loose where it attaches to the injector. I circled the location of the leak in the photo below. The blue infusion clamp was secured over the area, but i opened it in the picture for visualization of where the leak was occurring. Due to the loose connection, blood was then back flowing from the patient and leaking. ".
 
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Brand NameBD PHASEAL¿ OPTIMA INJECTOR (N40-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 Key13006127
MDR Text Key285473169
Report Number3003152976-2021-00824
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201099
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 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number515056
Device Catalogue Number515056
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2021
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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