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

Catalog Number	515057
Medical Device Problem Code	Shielding Failure (1568)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was exposed on the bd phaseal¿ optima injector n40-o multipack.The following was received by the initial reporter: right before drawing chemo with the phaseal optima injector attached to a syringe, the customer noticed the needle exposed within the optima injector.They saw that the injector lacked an internal membrane.They did not see the membrane inside the injector or anywhere in the hood.
Additional Manufacturer Narrative
H3.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 needle was exposed on the bd phaseal¿ optima injector n40-o multipack.The following was received by the initial reporter: right before drawing chemo with the phaseal optima injector attached to a syringe, the customer noticed the needle exposed within the optima injector.They saw that the injector lacked an internal membrane.They did not see the membrane inside the injector or anywhere in the hood.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or physicals samples that display the reported issue were provided for investigation.A device history review was performed for lot 2305309, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified, all injectors were properly assembled and no membranes were observed to be missing or disassembled.Product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device.No issues related to this issue were identified during the inspection process.It is possible a misalignment during assembly prevented the grips from properly joining and not fully assembling the injector.Given the device records do not indicate any issue and retained samples met required specifications, we cannot verify this to be true for the incident reported, therefore a definitive root cause cannot be established at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR N40-O MULTIPACK
• 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.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17804179
• Report Number: 3003152976-2023-00409
• Device Sequence Number: 6953502
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: (01)00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/23/2023

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: 10/31/2025
• Device Catalogue Number: 515057
• Device Lot Number: 2305309
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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