MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA PROTECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	515060
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phaseal optima protector the rubber disloged into the vial.There was no report of patient impact.The following information was provided by the initial reporter: vial where the adapter pushed in the stopper a little bit and they were not able to put diluent into the vial.Using p13-o.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no samples or photos received for investigation.A device history review was performed for lot 2202401, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples from the same lot were used for further evaluation.The protectors were successfully connected to the vials, ensuring that they fitted correctly.The product was evaluated, and no damage or defects were observed.Functional tests were performed on the samples and no leakage was identified between the protector and the vial.The product undergoes visual and functional testing throughout manufacturing, including leak testing.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported while using bd phaseal optima protector the rubber dislodged into the vial.There was no report of patient impact.The following information was provided by the initial reporter: vial where the adapter pushed in the stopper a little bit and they were not able to put diluent into the vial.Using p13-o.

• Brand Name: BD PHASEAL OPTIMA PROTECTOR
• 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 ; 8448235433
• MDR Report Key: 16592721
• Report Number: 3003152976-2023-00090
• Device Sequence Number: 17377753
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609
• 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
• 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): 05/16/2023

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: 01/31/2024
• Device Model Number: 515060
• Device Catalogue Number: 515060
• Device Lot Number: 2202401
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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