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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON PEN LIMITED BD PHASEAL OPTIMA CLOSED SYSTEM DRUG TRANSFER DEVICE - INJECTOR (N40-O); CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

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BECTON DICKINSON PEN LIMITED BD PHASEAL OPTIMA CLOSED SYSTEM DRUG TRANSFER DEVICE - INJECTOR (N40-O); CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Model Number 515056
Device Problem Disconnection (1171)
Patient Problem Insufficient Information (4580)
Event Date 06/28/2021
Event Type  malfunction  
Event Description
Patient was post-hydrating with normal saline solution (nss) following carboplatin.I was at the bedside and patient was sitting on mother's lap, not touching the tubing.The injector piece disconnected from the connector piece on the patient¿s port.
 
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Brand Name
BD PHASEAL OPTIMA CLOSED SYSTEM DRUG TRANSFER DEVICE - INJECTOR (N40-O)
Type of Device
CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
BECTON DICKINSON PEN LIMITED
1 becton drive
franklin lakes NJ 07417
MDR Report Key12142169
MDR Text Key260708166
Report Number12142169
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number515056
Device Catalogue Number515056
Device Lot Number2009603
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer07/09/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/09/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age365 DA
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