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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: it was reported that customer tried to puncture a 515628 into a thermo raw food and the rubber stopper gouged out during use.The subject 515628 seems to have been discarded.Additional information provided: customer response: q: can you check for leaks? a: confirmed, there is leakage.Q: did you have any problems inserting the spike into the iv bag? a: as usual, strong force was required at the time of puncture.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that the stopper became deformed when the c180-o spike was inserted into the iv bag.One iv bag was received for investigation.During visual inspection, the rubber stopper was found to have been pushed inward, verifying the reported concern.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 number involved in this incident is unknown, a device history review cannot be performed.Although no spike set was returned, bd has reviewed this report and identified a potential trend related to the reported concern.While we have verified our products are manufactured to approved specifications, 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 of the stopper.A project has been initiated to further investigate and address this issue.Our quality team will continue to monitor complaints related to this device and reported condition for any emerging trends.
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: 24765096
• Report Number: 3003152976-2026-00166
• Device Sequence Number: 18458423
• 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): 04/10/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/13/2026
• 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