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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
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
Event details: it was reported that during use the spike set fell out of the infusion bottle easily.A small amount of physiological saline solution leaked.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that the spike fell out of the infusion bag.One spike connector was provided to our quality team for evaluation.The product was thoroughly inspected, and no damage or defect was observed that could have contributed to the reported leak.Functional testing was performed by inserting the spike into an iv bag, injecting liquid into the iv bag, hanging the bag, and then withdrawing the solution; no disconnection occurred during these tests.A device history record (dhr) review was conducted for lot 2507506.No deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported event.The product undergoes multiple inspections during manufacturing to ensure quality and functionality, including verification that all critical dimensions meet specification.Results were reviewed for the reported lot and verified the product met required specification.While our investigation verifies that the product is manufactured to approved specifications, bd has reviewed this report and 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, which can result in leakage if not fully inserted.A project has been initiated to further investigate and address this issue.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: 24004861
• Report Number: 3003152976-2025-00713
• Device Sequence Number: 9405972
• Product Code: ONB
• UDI-Device Identifier: 00382905156281
• UDI-Public: (01)00382905156281
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2026

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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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