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

Catalog Number	515628
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd spike set c180-o had leakage.The following information was provided by the initial reporter: it was reported that the chemical leaked out from the area of the puncture site of the optima during use.Drug leaked - soldem (not an anticancer drug).
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
No additional information.
Additional Manufacturer Narrative
One iv bag along with the spike connector was provided to our quality team for evaluation.The product was thoroughly inspected, no damage or related to defect was observed that could have contributed to the reported leak.Further evaluation identified that the stopper of the iv bag is significantly torn.All products undergo visual and functional inspections throughout the manufacturing process to ensure device quality and performance, including verification that all critical dimensions meet specification.A device history review was conducted for lot 2507506, and no deviations or nonconformances related to the reported concern were identified.All records confirmed the product the meets required specifications, with no issues noted.While our investigation verifies that the product is manufactured to approved specifications, bd has identified a potential trend associated with this concern.It has been observed that the diameter of the c180 o spike can sometimes be larger than the ports of certain iv bags, resulting in higher insertion force and potential displacement or damage to the stopper.A project has been initiated to further investigate and address this issue.

• Brand Name: BD PHASEAL
• 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: 24300302
• Report Number: 3003152976-2026-00059
• Device Sequence Number: 9388673
• Product Code: ONB
• UDI-Device Identifier: 00382905156281
• UDI-Public: (01)00382905156281(11)250721(17)270630(10)2507506
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 515628
• Device Lot Number: 2507506
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown