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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL OPTIMA PHASEAL OPTIMA CONNECTOR C35-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
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BECTON DICKINSON BD PHASEAL OPTIMA PHASEAL OPTIMA CONNECTOR C35-O CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Model Number 515070
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/08/2021
Event Type  Injury  
Event Description
(b)(6) year old (b)(4) patient sitting in wagon. Rn picked up patient to remove from wagon and place in bed. Upon lifting patient, rn observed one of the two lumens of the broviac central line snap off. Patient returned to bed and central line assessed immediately. Iv infusions (ivf, pca, antibodies) were stopped at this time. Patient's broviac line was then clamped with sterile gauze to stop bleeding. Physicians called to bedside. Peds surg paged to assist with broviac repair. Repair was completed in treatment room. Antibodies had to be completed/restarted at 2000 that evening to ensure patient received daily dose. Ref report mw5103032. Fda safety report id# (b)(4).
 
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Brand NameBD PHASEAL OPTIMA PHASEAL OPTIMA CONNECTOR C35-O
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12287280
MDR Text Key265572873
Report NumberMW5103033
Device Sequence Number1
Product Code ONB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number515070
Device Catalogue Number515070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/05/2021 Patient Sequence Number: 1
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