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

Model Number	515053
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
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.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) experienced device damage while still considered operable.The following information was provided by the initial reporter: tech was finishing step of adding drug into bag, as he pulled phaseal optima n-35 to remove injector from phaseal optima adaptor (c100), the end of the white tip fell apart from the rest of white end, resulted in spring and parts inside of injector falling out.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) experienced device damage while still considered operable.The following information was provided by the initial reporter: tech was finishing step of adding drug into bag, as he pulled phaseal optima n-35 to remove injector from phaseal optima adaptor (c100), the end of the white tip fell apart from the rest of white end, resulted in spring and parts inside of injector falling out.
Additional Manufacturer Narrative
H6: investigation summary: no physical samples were available to our quality team for investigation.One photo was provided which shows the injector grips were separated and the injector was completed disassembled.There was no visible damage that could be identified within the photo on the grips or any of the components.A device history review was performed for lot 2205309, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Fifteen retained sample of the same lot were used for additional evaluation.The products were inspected and no damage within the grips were identified.Functional testing was performed, connecting the injector to a protector according to the instructions for use, connecting and disconnecting up to ten times.In all cases the product functioned as intended and no issues were observed.Product undergoes a series of visual and functional inspections throughout the manufacturing process, no issues were identified during the inspections performed for the reported lot.It is possible a misalignment during assembly prevented the grips from properly joining and not fully assembling.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.

• 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
• 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 ; 8015296192
• MDR Report Key: 16110111
• Report Number: 3003152976-2022-00598
• Device Sequence Number: 2019829
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: 00382905150531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• 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): 02/16/2023

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: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 515053
• Device Catalogue Number: 515053
• Device Lot Number: 2205309
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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