MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INJECTOR (N35-O MULTI); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515053
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) "fell apart" when connected with the protector during use.The following information was provided by the initial reporter: "after drug extraction the injector n35-0 was falling apart when connected with the protector.Membrane and spring was removed from the shield and one piece of the injector stayed on the protector"."yes the product was used for chemotherapy drug ¿ perjeta.".
Additional Manufacturer Narrative
H6: investigation summary two photos were provided to our quality team for investigation.Through visual inspection, the injector grips are observed to be separated, exposing the internal components.There is no visible damage noted in the photos on any of the components that may have contributed to this incident.Fifteen retained samples of lot 2004102 were used for additional evaluation.The product was visually inspected, no damage or defects were observed and all components were properly assembled.Functional testing was performed, connecting the injectors to a sample syringe, protector and vial according to the instructions for use.In all cases the product functioned properly, liquid inside the syringe could move to the vial and back to the syringe without issue, and no issues occurred during the connection or disconnection of the devices.It is possible that a misalignment of the injector grips during assembly resulted in the improper force being applied to join the components, therefore resulting in only partial assembly and the pieces disconnecting as observed in the product reported.A device history review was performed for lot 2004102, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this failure.Product undergoes visual and functionals inspections throughout the manufacturing.Testing results were reviewed for the reported lot, no issues related to this failure were identified, all product met required specification.Based on the available information we are not able to identify a definitive root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) "fell apart" when connected with the protector during use.The following information was provided by the initial reporter: "after drug extraction the injector n35-0 was falling apart when connected with the protector.Membrane and spring was removed from the shield and one piece of the injector stayed on the protector" "yes the product was used for chemotherapy drug ¿ perjeta.".

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N35-O MULTI)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10743820
• Report Number: 3003152976-2020-00476
• Device Sequence Number: 3884345
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: 00382905150531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (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): 12/03/2020

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: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 515053
• Device Lot Number: 2004102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1