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

Model Number	515057
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n40-o multi) leaked chemotherapy medication from the defective adapter.The following information was provided by the initial reporter: "1881-pc adriamycin dispensed by pharmacy and verified by two rns at chairside.Primary rn connected the adriamcyin syringe to an ns bag set to gravity via a dripless connector per policy.Once the rn attempted to administer the chemotherapy, it began flowing out of the chemo adapter.The adapter was noted to be defective.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n40-o multi) leaked chemotherapy medication from the defective adapter.The following information was provided by the initial reporter: "1881-pc adriamycin dispensed by pharmacy and verified by two rns at chairside.Primary rn connected the adriamcyin syringe to an ns bag set to gravity via a dripless connector per policy.Once the rn attempted to administer the chemotherapy, it began flowing out of the chemo adapter.The adapter was noted to be defective.
Additional Manufacturer Narrative
H6: investigation summary no samples or photos received by our quality team for evaluation.A review of the device history was performed for lot 2110310, no deviations or non-conformances related to the reported problem were identified during the manufacturing process.Three retained samples from the same lot were evaluated, no defects or issues observed.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.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.

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI)
• Common Device Name: 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 Key: 16943011
• Report Number: 3003152976-2023-00179
• Device Sequence Number: 6850507
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: 00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 515057
• Device Catalogue Number: 515057
• Device Lot Number: 2110310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown