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

Model Number	515105
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
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 2 bd phaseal¿ protector p50 experienced coring and particles found in the drug vial.The following information was provided by the initial reporter: enduser use bd phaseal for oncology drug compounding.Particles have been found in drug vial x2.Particles are suspected to be caused by coring when user insert bd protector onto the vial.
Additional Manufacturer Narrative
H6: investigation summary no samples or photos received for investigation.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.A device history review was performed for reported lot 2202131, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.It is important to ensure the vial is not expired as that can impact the quality of the rubber stopper.The protector must be fixed completely vertical to the vial during assembly.The m12 mounting accessory is recommended to facilitate the connection of the protector to the vial.Based on the available information we are not able to identify a definitive root cause at this time.
Event or Problem Description
It was reported that 2 bd phaseal¿ protector p50 experienced coring and particles found in the drug vial.The following information was provided by the initial reporter: enduser use bd phaseal for oncology drug compounding.Particles have been found in drug vial x2.Particles are suspected to be caused by coring when user insert bd protector onto the vial.

• 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
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16853939
• Report Number: 3003152976-2023-00154
• Device Sequence Number: 15345021
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: (01)00382905151057
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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 Model Number: 515105
• Device Catalogue Number: 515105
• Device Lot Number: 2202131
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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