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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O); INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O); INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 515056
Device Problems Leak/Splash (1354); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2021
Event Type  malfunction  
Event Description
It was reported that the tacro line disconnected from the bd phaseal¿ optima injector (n40-o) and leaked blood from the cvc lumen.The following information was provided by the initial reporter: "patient called nurse into room around 2100.Patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to.End of tubing had disconnected from phaseal injector.Large bubble was in part of tubing that enters casette.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation: no samples are available for the investigation of the event reported.Based on picture received; no damages or issues can be observed on n40-o product that could lead to the event reported.A device history review was performed for reported lot 2105303, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Ten retained samples from the same lot were evaluated no issues were observed on the luer cone nor the luer thread.No damages can be observed on retained samples requested.Leakage test performed, no defects were observed.Functional testing was performed, sample was attached to a syringe+ a protector connected to a vial.After aspirating the colorant from the vial to the syringe, no issues or leakage were found on the injector.No luer lock disconnection occurred.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Testing results were reviewed for the reported lot and found all product met required specifications.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h.10.
 
Event Description
It was reported that the tacro line disconnected from the bd phaseal¿ optima injector (n40-o) and leaked blood from the cvc lumen.The following information was provided by the initial reporter: "patient called nurse into room around 2100.Patient stated tacro line had disconnected and blood was dripping from cvc lumen that tacro was originally attached to.End of tubing had disconnected from phaseal injector.Large bubble was in part of tubing that enters casette.".
 
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Brand Name
BD PHASEAL¿ OPTIMA INJECTOR (N40-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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12821645
MDR Text Key284898043
Report Number3003152976-2021-00761
Device Sequence Number1
Product Code ONB
UDI-Device Identifier00382905150562
UDI-Public00382905150562
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201099
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 12/29/2021
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 Health Professional
Device Expiration Date10/31/2023
Device Model Number515056
Device Catalogue Number515056
Device Lot Number2105303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/18/2021
Initial Date FDA Received11/16/2021
Supplement Dates Manufacturer Received12/29/2021
Supplement Dates FDA Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2021
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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