MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA; BD PHASEAL¿ OPTIMA SPIKE SET (C180-O)

Catalog Number	515628
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr.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
Event details: it was reported that the drug started leaking out while puncturing the spike during preparation of docetaxel.The infusion bag is a saline solution from kosha.The injector (containing docetaxel) when it was being prepared is also enclosed.
Additional Manufacturer Narrative
Device evaluation one iv bag assembled with a spike connector was provided to our quality team for evaluation.Upon evaluation it was noted that the stopper of the iv bag is torn.Dimensional testing was performed and identified that the spike diameter is too large for use with this iv bag.All products undergo visual and functional inspections throughout the manufacturing process to ensure device quality and performance, including verification that all critical dimensions meet specification.A device history review was conducted for lot 2507506, and no deviations or nonconformances related to the reported concern were identified.All records confirmed the product the meets required specifications, with no issues noted.While our investigation verifies that the product is manufactured to approved specifications, bd has identified a potential trend associated with this concern.It has been observed that the diameter of the c180 o spike can sometimes be larger than the ports of certain iv bags, resulting in higher insertion force and potential displacement of the stopper.A project has been initiated to further investigate and address this issue.

• Brand Name: BD PHASEAL OPTIMA
• Common Device Name: BD PHASEAL¿ OPTIMA SPIKE SET (C180-O)
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24233588
• Report Number: 3003152976-2026-00032
• Device Sequence Number: 18385311
• Product Code: ONB
• UDI-Device Identifier: 00382905156281
• UDI-Public: (01)00382905156281(11)250721(17)270630(10)2507506
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250059
• 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): 03/16/2026

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: Other
• Device Catalogue Number: 515628
• Device Lot Number: 2507506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown