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

Catalog Number	515106
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Foreign object in bag.Event details: prepared 1 vial of 100 ml paclitaxel and 1 vial of 30 ml paclitaxel, then checked the bag and found a single foreign object.Eight vials of paclitaxel nk 30 ml were prepared, and after collecting the liquid from each vial, it was infused into the infusion bag.Before the infusion bag was handed over to the nurse, the person in charge checked the bag and found multiple foreign objects.The lot number of the injector is unknown.The incident occurred after connecting the protector and injector.The connection was made approximately 10 times.The product that was connected to the infusion bag was 515309.
Additional Manufacturer Narrative
Follow up mdr for device evaluation/correction: based on investigation results, this complaint is no longer reportable.The involved device did not contribute to the reported failure, coring.It was reported that particles were observed inside the iv bag.For investigation, two iv bags, two l-connectors, and a device not manufactured by bd were provided to our quality team.Upon inspection, gray particles were observed inside both infusion bags, verifying the reported concern.The particles were evaluated under a microscope, and it was determined that they are consistent with material from the rubber stopper of the infusion bag.No damage or related defects were identified within our device that could have contributed to this observation.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.As a lot number was unavailable for this incident, a device history record review could not be completed.Coring of the rubber stopper may occur depending on stopper quality, design, or if a poor connection is made.Based on the available information, a definitive root cause cannot be identified at this time.
Event or Problem Description
No additional information.

• 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: 22329829
• Report Number: 3003152976-2025-00324
• Device Sequence Number: 9354854
• Product Code: ONB
• UDI-Device Identifier: 00382905151064
• UDI-Public: (01)00382905151064
• 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): 01/14/2026

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: UNKNOWN
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown