MAUDE Adverse Event Report: BECTON DICKINSON PHASEAL; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515106
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11.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
Description: coring.Event details: it was reported that coring during circulisa preparation.Confirmed in vial after connecting protector and injector.The size suggests that it was caused by passing through the air needle of the protector.Injector lot is 2409011 and part number is 515005.
Event or Problem Description
Description: coring.Event details: it was reported that coring during circulisa preparation.Confirmed in vial after connecting protector and injector.The size suggests that it was caused by passing through the air needle of the protector.Injector lot is 2409011 and part number is 515005.The protector is assembled manually.As described in the pir, coring was found at the timing of collecting the drug after connecting the protector and injector.The drug was collected and infused into the infusion bag avoiding foreign substances.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: one protector connected to a vial was provided to our quality team for investigation.Through visual inspection, a grey particle was observed.Using magnification it was found the particle is consistent with material from the stopper of the vial.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.A device history review was performed for protector lot 2411101, no deviations or non-conformances were identified during the manufacturing process that could have contributed to incident.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.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.Based on our investigation and sample evaluation, it was determined the particles generated during the assembly of the protector onto the vial.No issues related to the injector used were found.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.

• Brand Name: PHASEAL
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22441316
• Report Number: 3003152976-2025-00366
• Device Sequence Number: 8028897
• Product Code: ONB
• UDI-Device Identifier: 00382905151064
• UDI-Public: (01)00382905151064(17)291031(10)2411101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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 Catalogue Number: 515106
• Device Lot Number: 2411101
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown