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

Model Number	515105
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd phaseal¿ protectors p50 caused coring to occur in the medication vials during the drug compounding.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
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¿ protectors p50 caused coring to occur in the medication vials during the drug compounding.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
Correction: after further evaluation of the complaint, it has been determined that the mdr 3003152976-2023-00149 is a duplicate of 3003152976-2023-00154 this supplemental is to cancel mdr 3003152976-2023-00149.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16807287
• Report Number: 3003152976-2023-00149
• Device Sequence Number: 6151677
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: 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): 04/26/2023

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: 02/20/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/02/2023
• 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