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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515070
Device Problems Leak/Splash (1354); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2022
Event Type  malfunction  
Event Description
It was reported that during use on at least 4 occasions the bd phaseal¿ optima infusion connector c35-o the luer connector separated and chemotherapy spilled on the patients clothing.There was no report of patient impact.The following information was provided by the initial reporter: this connector was connected directly to the patient's iv.During the infusion this part disconnected from the patient's iv.Thus the chemotherapy agent spilled on the patient's clothing.This product has a tendency to get disconnected, particularly at the connection point, thus exposing caregivers to chemotherapy agents.This is the first report we submit, however we had at least 3 similar events.I instructed the team to report any additional event.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that during use on at least 4 occasions the bd phaseal¿ optima infusion connector c35-o the luer connector separated and chemotherapy spilled on the patients clothing.There was no report of patient impact.The following information was provided by the initial reporter: this connector was connected directly to the patient's iv.During the infusion this part disconnected from the patient's iv.Thus the chemotherapy agent spilled on the patient's clothing.This product has a tendency to get disconnected, particularly at the connection point, thus exposing caregivers to chemotherapy agents.This is the first report we submit, however we had at least 3 similar events.I instructed the team to report any additional event.
 
Manufacturer Narrative
H6: investigation summary: no physical samples that display the reported condition were provided for investigation.A device history review was performed for lot 2201507, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Dimensional testing was performed, including the luer thread, verifying all critical dimensions are within specification.Product undergoes a series of visual and functional evaluations throughout the manufacturing process.Records were reviewed for the reported lot and no issues related to this failure were identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
 
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Brand Name
BD PHASEAL¿ OPTIMA INFUSION CONNECTOR C35-O
Type of Device
INTRAVASCULAR 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
8448235433
MDR Report Key16475470
MDR Text Key310632266
Report Number3003152976-2023-00039
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,Followup
Report Date 03/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2023
Device Catalogue Number515070
Device Lot Number2201507
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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