MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL; INJECTOR LOCKING N40-O

Catalog Number	515056
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: doxorubicin push medication leaking when being administered through phaseal optima.Causing drug loss and hazardous drug exposure.Phaseal optima injector for chemotherapy push of doxorubicin not stopping the flow of chemotherapy from the syringe it was contained in.Doxorubicin leaking and dripping at the end of the device upon arrival to 4 onc.The leaking chemotherapy also made the phaseal optima connector pop loose during the push and required the connector being held in and constantly pushed back in as well as chemotherapy oozing out the side at times.Rn (b)(6) reports this is the second time she has seen this recently.Per rep response on 22dec2025: i have requested lot number information but do not have that information yet.The impact to patient would be delay in care, amount of drug received, and hazardous drug exposure to patient and staff.
Additional Manufacturer Narrative
Four photos were provided to our quality team for investigation.Upon visual evaluation, evidence of leakage is observed, verifying the reported concern.Our products undergo comprehensive inspections throughout the manufacturing process to ensure device quality and performance.These inspections include verification that all critical dimensions meet specifications, confirmation that the product is free from damage, and leakage testing.As the lot involved in this incident is unknown, a device history review could not be performed.Based on the photos, and without the physical sample to further evaluate, a definitive cause cannot be established at 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
• Common Device Name: INJECTOR LOCKING N40-O
• 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: 24095728
• Report Number: 3003152976-2025-00729
• Device Sequence Number: 16017299
• Product Code: ONB
• UDI-Device Identifier: 00382905150562
• UDI-Public: (01)00382905150562
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• 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: 515056
• Device Lot Number: UNKNOWN
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown