MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Model Number	515105
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ protector p50 leaked medicine from the connection to the vial while drawing it up.The following information was provided by the initial reporter: "after the pharmacist attached the p50 to the vial, and during the drawing of drug, the drug seems to be leaking from the site connection of the protector and the vial.The pharamcist then puts the drug into the bag and shake it inside the bag.Droplets formed inside the bag indicating a leak.A sample could not be sent back as it is contaminated with cytotoxic drug.".
Event or Problem Description
It was reported that the bd phaseal¿ protector p50 leaked medicine from the connection to the vial while drawing it up.The following information was provided by the initial reporter: "after the pharmacist attached the p50 to the vial, and during the drawing of drug, the drug seems to be leaking from the site connection of the protector and the vial.The pharamcist then puts the drug into the bag and shake it inside the bag.Droplets formed inside the bag indicating a leak.A sample could not be sent back as it is contaminated with cytotoxic drug.".
Additional Manufacturer Narrative
H.6.Investigation: one photo sample was returned to our quality team for investigation.Through visual inspection, droplets can be observed between the protector and vial.Based on the photo, it appears that the aluminum cap and the rubber stopper were not properly encapsulated to the vial, however, without the physical sample this cannot be definitively identified.A device history review was performed for reported lot 1803101, 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 inspected and no damage or defects were observed.The protectors were successfully connected to the vials, ensuring they fit properly.Functional testing was performed, liquid could move from the vial to the syringe and back without issue and no leakages were observed.Product undergoes visual and functional testing throughout manufacturing, including leakage testing and verification that all critical dimensions are within specification.Results were reviewed for lot 1803101 and no issues related to the reported event were found.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

• Brand Name: BD PHASEAL PROTECTOR P50
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11579863
• Report Number: 3003152976-2021-00172
• Device Sequence Number: 3622381
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: 30382905151058
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 515105
• Device Catalogue Number: 515105
• Device Lot Number: 1803101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1