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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INFUSION ADAPTER (C100-O) INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INFUSION ADAPTER (C100-O) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515078
Device Problem Fitting Problem (2183)
Patient Problem Muscle/Tendon Damage (4532)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 bd phaseal¿ optima infusion adapter (c100-o) was difficult to connect to the b. Braun infusion bags. The following information was provided by the initial reporter: "two technicians had similar hand/finger injuries due to repetitive strain. The technicians report that the phaseal infusion adapter requires more force and twisting to insert to bbraun infusion bags, and also the injector and protector pieces require additional force to withdraw and inject solutions due to the small needle gauge size used. ".
 
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Brand NameBD PHASEAL OPTIMA INFUSION ADAPTER (C100-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 Key12616261
MDR Text Key276862115
Report Number3003152976-2021-00679
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 distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515078
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 Received09/13/2021
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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