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	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event details: after preparing the chemotherapy drug, when attempting to administer it in the chemotherapy room, the drug leaked from near the spike.A connecting tube was attached to another bag of intravenous fluid, and the drug was administered from that bag.The preparation process was the same as usual, and there were no abnormalities during the preparation.The saline solution used was fuso 250ml.When connecting the plastic needle of the connecting tube in order to transfer from the relevant infusion bag to another infusion bag, access to the rubber stopper failed once, and the connecting tube was successfully connected after the second access.Therefore, there are two puncture holes in the rubber stopper of the relevant infusion bag other than the spike that is stuck in it, but they are irrelevant because they were made after this event.Drug leakage.
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one iv bag assembled with a spike connector was provided to our quality team for evaluation.Functional testing was performed and a leakage between the spike and iv bag was observed.Further evaluation identified the stopper of the iv bag was cracked.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 2506602, and no deviations or nonconformances related to the reported concern were identified.All records confirmed the product met specifications, with no issues noted.Bd has reviewed this report and identified a potential trend related to this concern.While we have confirmed that our product is manufactured to approved specifications, a project has been initiated to further investigate and address this matter.Complaints received for these devices and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• 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.; camino de valdeolivia; s/n; san agustin de guadalix 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24075275
• Report Number: 3003152976-2025-00727
• Device Sequence Number: 10266641
• Product Code: ONB
• UDI-Device Identifier: 00382905156281
• UDI-Public: (01)00382905156281(11)250619(17)270531(10)2506602
• 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): 03/05/2026

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: 2506602
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown