MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA PROTECTOR P13-O; INTRAVASCULAR ADMINISTRATION SET

Model Number	515060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
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 skirt was broken on the bd phaseal¿ optima protector p13-o.The following information was provided by the initial reporter: the plastic skirt around the vial broke and came off.
Additional Manufacturer Narrative
H6: investigation summary; four photos were provided to our quality team for investigation.Upon visual inspection, it was observed that one of the vial claws was broken.A device history review was performed for lot 2104401, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples from the same lot were used for further evaluation.The product was inspected and no damage or defects were observed.Functional testing was performed, connecting the protectors to a vial, along with an injector and syringe according to the instructions for use.In all cases the spike properly penetrated the vial stopper, all product functioned as intended and no damage occurred to the protector.Product undergo visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device.All results for lot 2104401 were reviewed and the results were acceptable, no issues related to the reported defect were identified.Based on the information available, we are unable to identify a root cause related to the manufacturing process at this time.H3 other text : see h10.
Event or Problem Description
It was reported that the skirt was broken on the bd phaseal¿ optima protector p13-o.The following information was provided by the initial reporter: the plastic skirt around the vial broke and came off.

• Brand Name: BD PHASEAL¿ OPTIMA PROTECTOR P13-O
• 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: 14860967
• Report Number: 3003152976-2022-00301
• Device Sequence Number: 20161126
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: 00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 03/31/2023
• Device Model Number: 515060
• Device Catalogue Number: 515060
• Device Lot Number: 2104401
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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