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 Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
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: material # 515052 batch # 2402307 verbatim: rcc received a complaint via email.Email(s) attached.An rn entered the patient's room to find the tacrolimus iv tubing disconnected from bd phaseal n-35 injector.Approximately 5ml of medication was found on the floor.The rn contained and cleaned the spill.The covering provider was notified.Per nursing note: "pt's tacro tubing became disconnected at the site of iv tubing and the chemo safety chemo connection.Pharmacy mixed a new bag.Purple lumen cap changed and new bag of tacro and it's tubing changed and started immediately upon its arrival " additional information provided: 1.Could you please provide the material & lot number of the iv tubing that was involved in this event ? unknown 2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No harm resulted, as pharmacy mixed a new bag of tacro, purple lumen of central line was changed, new phaseal connector and new tubing was obtained to complete the treatment.3.In the medsun form mentioned that the date of the event as ¿(b)(6) 2025¿.Could you please specify the exact date when the reported issue happened? (b)(6) 2025 4.Any physical sample available for investigation? no, it was discarded 5.Have you confirmed that the connections were properly secured? per the unit¿s review of the event, all connections were properly secured.6.Were there any deformities? none noted 7.What kind of drug was used? tacrolimus 2.5mg in 250ml ns 8.Kindly provide the exact location of leakage.Per nursing note, ¿pt's tacro tubing became disconnected at the site of iv tubing and the chemo safety chemo connector.¿ 9.If pump was being used, kindly provide the rate of infusion.10.63ml/hr 10.Have you replaced the defective injector and successfully completed the medication procedure? yes, it was replaced and treatment was completed.
Additional Manufacturer Narrative
Additional information: 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, and no deviations or non-conformance's were found during the manufacturing process that could have contributed to the issue.The defect could not be confirmed, and the root cause remains unknown as the customer did not provide samples or photographs.The product undergoes inspections at various stages of the manufacturing process to ensure its quality and functionality.
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: 24299821
• Report Number: 3003152976-2026-00057
• Device Sequence Number: 18683350
• Product Code: ONB
• UDI-Device Identifier: 00382905150524
• UDI-Public: (01)00382905150524(10)2402307
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 515052
• Device Lot Number: 2402307
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male