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	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event details: it was identified that the leak was between the bag stopper and the c180-o spike.
Additional Manufacturer Narrative
A leak was reported near the adapter port of the c83o connecting set.The quality team received one c83o connecting set, a c180o spike set, and the iv bag for evaluation.Through visual inspection, it was noted the stopper of the bag was cracked, creating a larger opening.Functional testing was performed and identified a leakage between the iv bag stopper and the c180o spike set, however, no leakages were noted at the infusion adapter of the c83o.An overpressure test was then conducted on the c83o connecting set by submerging it in water and applying pressure; again no leaks were observed.A device history review was performed for c180o lot 2506602, no deviations or non-conformances related to this observation were identified during the manufacturing process.All products undergo multiple inspections throughout production to ensure quality and functionality, and no issues associated with the reported event were identified during these inspections.Based on our investigation, the leakage was observed between the connection of the spike set and the stopper of the iv bag, noting the stopper is significantly cracked.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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24027269
• Report Number: 3003152976-2025-00719
• Device Sequence Number: 9201503
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 515628
• Device Lot Number: 2506602
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/09/2026
• 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