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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 515170
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or physical samples that display the reported condition were available for investigation. Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device. As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated. Based on the available information we are not able to identify a root cause at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the injector separated from the bd phaseal¿ optima connector (c35-o) during the 3-hour taxol infusion. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter: "the n40 became disconnected from the connector on a 3 hour taxol infusion. " "there was no impact to the patient or user. No exposure to a hazardous drug. ".
 
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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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12523321
MDR Text Key273144319
Report Number3003152976-2021-00635
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
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515170
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2021
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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