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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
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
It was reported that the bd spike set c180-o fell out of bag.The following information was provided by the initial reporter: it was reported that after adjusting the 5fu and dispensing the infusion bag, the nurse was about to start administering when the spike set fell out of the infusion bag during use.The infusion bag had been discarded.Please follow up and request the brand/manufacturer of the iv bag? was the spike fully inserted into the bag? is the lot information available? customer response- 1.Terumo 2.Yes, it was.3.Unknown.
Additional Manufacturer Narrative
Device evaluation: it was reported that the spike fell out of the infusion bag.One spike connector was provided to our quality team for evaluation.Upon inspection, no damage or defects were observed within the product.All product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.As the lot involved in this incident is unknown, a device history review could not be performed.Although we could not replicate the reported incident, bd has reviewed this report and identified a potential trend related to the reported concern.While we have confirmed our product is manufactured to approved specifications, a project has been initiated to further investigate and address this matter.
Event or Problem Description
No additional information.

• 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: 24317061
• Report Number: 3003152976-2026-00062
• Device Sequence Number: 17362324
• Product Code: ONB
• UDI-Device Identifier: 00382905156281
• UDI-Public: (01)00382905156281
• 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: 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/11/2026
• 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