MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PHASEAL OPTIMA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515052
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd injector n35-o luer lock disconnected.The following information was provided by the initial reporter: it was reported that after adjusting 5fu, while infusing into the infuse pump, the injector was detached from the syringe, and the chemical was splashed during use.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one n35-o injector along with a syringe that is not manufactured by bd, was provided to our quality team for investigation.Upon visual inspection of the returned product, no damage or defects were identified.Functional testing confirmed that the injector connected securely to the mating luer without issue.Dimensional testing of the injector¿s luer threading was also performed.No conditions were identified that would contribute to a disconnection between the optima injector and the syringe.The iso luer lock threads met all required specifications, and all measured dimensions were within tolerance.The product undergoes routine visual and functional testing throughout the manufacturing process to ensure quality and proper device performance, including verification that all critical dimensions meet specification.Because the lot number associated with this incident was not available, a device history review could not be completed.Based on the investigation, no root cause related to the product or manufacturing process could be identified at this time.Complaints related to this device and reported condition will continue to be monitored and trended.The quality team regularly reviews this data to identify any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: PHASEAL OPTIMA
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 24274300
• Report Number: 3003152976-2026-00049
• Device Sequence Number: 10658310
• Product Code: ONB
• UDI-Device Identifier: 00382905150524
• UDI-Public: (01)00382905150524
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: UNKNOWN
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown