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

Catalog Number	515070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd connector c35-o had leakage between the injector and connection, the following information was provided by the initial reporter: material # 515052, 515070 batch # 2505303, 2502502.We ran into an issue here when using the pharseal optima injector (lot 2505303) and phaseal optima connecter (lot 2502502).The two pieces did not click together to lock.There was a gap between the 2 pieces and when nursing administered methotrexate subcutaneously it started to leak between the two pieces.I have the syringe and phaseal pieces (+ needle) with me for follow up.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that the pieces could not click together and a leakage occurred during use.One injector assembled with one connector was provided to our quality team for investigation.Upon inspection, no damage or related defect was observed on the products and the components were verified to fully assemble without issue.Functional testing was performed and liquid moved throughout the system without issue, no disconnections or leakages were observed.A device history review was conducted for injector lot 2505303 and connector lot 2502502.No deviations or non-conformances related to the reported issue were identified during the manufacturing process.All products undergo multiple inspections throughout production to ensure quality and functionality, including attachment and detachment force testing.Testing was performed on the returned products and verified the product met required specifications.Based on our investigation and sample evaluation, no issues were found with the product or lots reported, therefore a root cause cannot be established at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 24644073
• Report Number: 3003152976-2026-00143
• Device Sequence Number: 10207821
• Product Code: ONB
• UDI-Device Identifier: 00382905150708
• UDI-Public: (01)00382905150708(11)250213(17)270131(10)2502502
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/28/2026

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: 515070
• Device Lot Number: 2502502
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown