MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD Phaseal; Closed antineoplastic and hazardous drug reconstitution and transfer system

Catalog Number	515629
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: the device history record (dhr) for lot 2603509, reference 515629 product set c83-o was reviewed, and no deviations or non-conformances were identified that could be related to the reported event.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Three retained samples of the c83-o set, lot 2603509, reference 515629, were received for evaluation of the condition reported by the customer.A detailed visual inspection was performed on all three returned samples.No anomalies, damage, or deviations were identified that could be associated with the reported failure mode.As part of the investigation, functional testing was conducted by connecting each of the three retained samples to an n40-o injector.All evaluated units were successfully connected to the luer adapter, achieving proper engagement and locking as intended by the product.No abnormalities or performance issues were observed during testing.

• 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 ; +1(847)393-5694
• MDR Report Key: 50862364
• Report Number: 3003152976-2026-00448
• Device Sequence Number: 10025618
• Product Code: ONB
• UDI-Device Identifier: 00382905156298
• UDI-Public: (01)00382905156298(11)260330(17)280229(10)2603509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/29/2026

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: 2603509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown