MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA CONNECTING SET (C83-O); CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515629
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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: while administering medication by connecting the optima iv line connection kit to the optima spike set attached to the infusion bag, the injector part of the optima iv line connection kit (the disc below the luer) disassembled and came off, causing a metal spring to fly out.Concurrently, the anticancer drug cisplatin leaked.The nurse hurriedly pushed the detached part back in to stop the leak.The anticancer drug administration was temporarily halted.The medication was reconstituted, and administration resumed using a new iv line connection kit.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that the injector came apart during administration.One c83-o connecting set was returned to our quality team for evaluation.The product was thoroughly inspected, and no damage or defects were observed that would have caused it to separate.A device history review was performed for lot 2506603, and no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported concern.Product undergoes a series of visual and functional inspections throughout the manufacturing process, including verification that all critical components are within specification and free from damage.No issues were noted during any of these inspections for the reported lot.While a misalignment during assembly or a crack in the grip could potentially allow the spring to eject during use, retained samples from the same lot were evaluated and no damage to the grips was observed.Based on our investigation and sample evaluation, no damage or defects were found within the injector or its components; therefore, we cannot identify a definitive root cause at this time.Complaints for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL¿ OPTIMA CONNECTING SET (C83-O)
• 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: 23423902
• Report Number: 3003152976-2025-00596
• Device Sequence Number: 8253583
• Product Code: ONB
• UDI-Device Identifier: 00382905156298
• UDI-Public: (01)00382905156298
• 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,Followup
• Report Date (Section B): 03/05/2026

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: 515629
• Device Lot Number: 2506603
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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