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

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event unknown so bd awareness date used.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: i am hoping you can point me in the right direction of who to speak with regarding a concern with our phaseal pieces.I have been using phaseal for over 10 years to administer chemotherapy, recently i have had two bottles of vincristine leak significantly at the point where the protector p14 is attached.I did inspect the bottle to ensure the p14 was applied correctly and "snapped in" to the lid, which it was.Since this is the second time this has happened, i wanted to reach out to see if this was a known problem or if you have any suggestions on how to avoid this in the future.
Additional Manufacturer Narrative
Additional information: (b) date of event has since been provided; added additional customer response (d) added catalog #, lot details, and udi (g) added 510(k) (h) added device mfg date 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 for protector p14 lot 2410113, and no deviations or non-conformances were found during the manufacturing process that could have contributed to the issue.Three samples were assembled with the corresponding vials using the m12-o, and a functional test was performed by connecting the assembled protector and vial to an injector and a syringe.Liquid was passed through the entire assembly, and the leakage could not be reproduced in any of the three protectors received.The product undergoes inspections at various stages of the manufacturing process to ensure its quality and functionality.Based on the information available, we are currently unable to identify a root cause related to the manufacturing process.Our quality team will continue to monitor complaints received for this device and the reported condition for any potential emerging trends.
Event or Problem Description
Additional information: the assembly fixture was used for this event? if the assembly fixture is the "handle" then yes.Bottle and phaseal protector were locked into place correctly.

• Brand Name: 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: 23413360
• Report Number: 3003152976-2025-00593
• Device Sequence Number: 8945413
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002(11)241014(17)290930(10)2410113
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 515100
• Device Lot Number: 2410113
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown