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	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event details: it was reported that when a spike was punctured into the infusion set, the medication leaked out from the side where the spike was punctured.(infusion bottle terumo soldem).
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
No additional information.
Additional Manufacturer Narrative
Pr 13980711 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, noting the stopper of the iv bag is torn.Additional evaluation determined that the spike diameter was 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 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: 24233450
• Report Number: 3003152976-2026-00031
• Device Sequence Number: 10175376
• 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): 03/05/2026

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: 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: 03/04/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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