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	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n35-o multi) experienced needle exposure during use.The following information was provided by the initial reporter: i wanted to bring to your attention an issue we had with an optima injector yesterday.Injected a hazardous drug into a bag, and when he pulled the syringe off the infusion adapter, the seal came out of the injector leaving the needle exposed within the injector sleeve.Seal piece from inside the injector sleeve is on top of the packaging.I am not sure if anyone else has had this issue.
Additional Manufacturer Narrative
A sample is available for evaluation.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 needle exposure during use.The following information was provided by the initial reporter: i wanted to bring to your attention an issue we had with an optima injector yesterday.Xxxx injected a hazardous drug into a bag, and when he pulled the syringe off the infusion adapter, the seal came out of the injector leaving the needle exposed within the injector sleeve.Seal piece from inside the injector sleeve is on top of the packaging.I am not sure if anyone else has had this issue.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-oct-2022.H6: investigation summary one sample and one photo was provided to our quality team for investigation.Through visual inspection, the membrane was observed to have separated from the injector.Further evaluation identified that the hole on the bottom of the membrane was clogged which likely prevented proper assembly between the membrane and injector cannula during assembly.A device history review was performed for lot 2111311, 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 clogged.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.While we cannot identify a direct issue, the clog within the membrane likely prevented proper assembly and lead to the membrane disconnecting from the injector as observed in the product evaluated.

• 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: 15182855
• Report Number: 3003152976-2022-00355
• Device Sequence Number: 12373982
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: 00382905150531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/19/2022

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: 04/30/2024
• Device Model Number: 515053
• Device Catalogue Number: 515053
• Device Lot Number: 2111311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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