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

Catalog Number	515052
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
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: patient got up to use the rest room and noticed there was some of her chemotherapy leaking from the tube along the floor.It appeared to be leaking from a connection piece, but had not previous leaked when there ivf administered prior to the administration of the drug.Piece noted to be leaking was phaseal optima 515052 lot 2501305 exp: 6/30/27 kyprolis started at 1354.Pt then got up to use the bathroom.She then noticed that her line was leaking while in the bathroom.She called out for the rn.Rn paused infusion at 1355 and noticed that it was leaking from where the primary iv tubing attaches to the closed system transfer device via luer lock connection.Connection tightened.Blood return confirmed from port.Infusion restarted.Kyprolis noted on pt's hands and several drops on the bathroom floor.Pt diligently washed her hands x2.Medication cleaned up with chemo spill pad and bleach.Pt successfully completed infusion.
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 lot 2501305, 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.Upon visual inspection, no deformations, material shortages, burrs, or breakages were detected.All products were found to be in optimal and acceptable condition.Luer thread tests were performed on the retained samples, confirming that the product functions as expected.The tests were carried out in accordance with internal procedures.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
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23527011
• Report Number: 3003152976-2025-00630
• Device Sequence Number: 9065680
• Product Code: ONB
• UDI-Device Identifier: 00382905150524
• UDI-Public: (01)00382905150524(11)250117(17)270630(10)2501305
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• 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): 02/23/2026

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: 515052
• Device Lot Number: 2501305
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/22/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown