MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA; INJECTOR (N35-O MULTI)

Catalog Number	515053
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event details: disconnection between alaris tubing and optima injector leading to chemo spill.
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: no photographic evidence or physical samples were provided to investigate the reported condition.A thorough review of the device's history was conducted for optima injector n35-o-multi lot 2506305, and no deviations or non-conformances were found during the manufacturing process that could have contributed to the issue.Three retained samples were received for further evaluation, and during the visual inspection no damage or anomalies were identified.The metrology test performed, no anomalies were detected in the retained samples that could result in luer lock disconnection.The following dimensions were verified by quality metrology team, the results meet the specifications.The product undergoes inspections at various stages of the manufacturing process to ensure its quality and functionality.Based on the information available, we are currently unable to identify a root cause related to the manufacturing process.Our quality team will continue to monitor complaints received for this device and the reported condition for any potential emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD PHASEAL OPTIMA
• Common Device Name: INJECTOR (N35-O MULTI)
• 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: 23879664
• Report Number: 3003152976-2025-00685
• Device Sequence Number: 17320046
• Product Code: ONB
• UDI-Device Identifier: 00382905150531
• UDI-Public: (01)00382905150531(10)2506305
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 515053
• Device Lot Number: 2506305
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown