MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA; INFUSION ADAPTOR (C100-O)

Catalog Number	515078
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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: pharmacy technician attached device to iv bag and noticed solution leaking.Upon visual inspection, it appears the device was defective.Complaint noticed: prior to use.Problem frequency: 1st time.Patient injury: no.Qty affected: 1 each.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one sample was provided to our quality team for investigation.Upon inspection, the connection stick is broken off from the adapter body, verifying the reported concern.A device history review was performed for lot 2502505, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.Retained samples of the same lot were used for additional evaluation.The product was thoroughly inspected, no defects were observed within any of the samples.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.All results were reviewed for lot 2502505 and no issues were identified related to the reported incident.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.It appears the break occurred due to excessive force when engaging the device.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr 13297549 follow up mdr for correction: after submission of suppl.Mdr for device evaluation, it was identified the incorrect investigation codes were submitted.Annex c and annex d codes updated to more accurately reflect findings.

• Brand Name: BD PHASEAL OPTIMA
• Common Device Name: INFUSION ADAPTOR (C100-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: 23512628
• Report Number: 3003152976-2025-00619
• Device Sequence Number: 21258967
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784(11)250218(17)270131(10)2502505
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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: Health Professional
• Device Catalogue Number: 515078
• Device Lot Number: 2502505
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 02/19/2026; 02/19/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/19/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown