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

Model Number 515064

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a video was provided to our quality team for investigation.Through visual inspection of the video, white particles were observed throughout the liquid in the vial, however, without the physical sample we cannot adequately identify the composition or origin of the particles observed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including fragmentation testing to evaluate any particulates generated by the injector when mated to other components after ten activations.As a lot number was unavailable for this incident, a device history record review could not be completed and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a failure or root cause related to our product or manufacturing process at this time.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.

Event Description

It was reported that flake-like foreign matter was found in the drug vial after reconstituting it with diluent from the bd phaseal¿ optima injector (n35-o).The following information was provided by the initial reporter: "a couple of years ago there was an issue with a cstd with the drug ogiviri.Apparently the drug company sent it out to an external lab and found oil residue on the spike (of the protector).(compounding supervisor) is not sure if it was phaseal or another cstd used at the time.The situation is now recurring.The drug company.Wants her to send a protector and injector for them to evaluate since it looks like flakes of lemonade in the vial when reconstituted using the provided diluent.Is indicating that the cstd (phaseal optima) is the cause.The vials were kept in the fridge before and after reconstitution." "they reconstituted an ogiviri yesterday without phaseal optima and it contained little strands.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-sep-2022 investigation summary one video along with the physical sample was provided to our quality team for investigation.Through visual inspection of both video and sample, white particles were observed throughout the liquid in the vial.The particles were filtered from the liquid and characterization testing was performed to identify the composition.Results found the particles inside the vial were consistant with material from the rubber stopper of the vial.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including fragmentation testing to evaluate any particulates generated by the injector when mated to other components after ten activations.As a lot number was unavailable for this incident, a device history record review could not be completed.

Event Description

It was reported that flake-like foreign matter was found in the drug vial after reconstituting it with diluent from the bd phaseal¿ optima injector (n35-o).The following information was provided by the initial reporter: "a couple of years ago there was an issue with a cstd with the drug ogiviri.Apparently the drug company sent it out to an external lab and found oil residue on the spike (of the protector).(compounding supervisor) is not sure if it was phaseal or another cstd used at the time.The situation is now recurring.The drug company wants her to send a protector and injector for them to evaluate since it looks like flakes of lemonade in the vial when reconstituted using the provided diluent.Is indicating that the cstd (phaseal optima) is the cause.The vials were kept in the fridge before and after reconstitution." they reconstituted an ogiviri yesterday without phaseal optima and it contained little strands.

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR (N35-O)
• Type of Device: 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: 13955821
• MDR Text Key: 288294202
• Report Number: 3003152976-2022-00121
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: 00382905150647
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 515064
• Device Catalogue Number: 515052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1