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	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: it was reported that when the customer inserted the optima spike into the soldem and then removed it, damage to the rubber stopper was observed during use.The stopper was thick, so it appeared to have been gouged out.At that time, there did not seem to be any leakage.
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: one iv bag was received for investigation.During visual inspection, the rubber stopper was found to have been significantly cracked, verifying the reported concern.There was no damage or other defect identified within the spike that could have contributed to this observation.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.A device history review was conducted for lot 2507506.No deviations or non-conformances related to the reported concern were identified during the manufacturing process.Results confirmed the product met specification, with no issues identified.Although the investigation confirmed that the product was manufactured to approved specifications, bd has identified a potential trend associated with this concern.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 or damage to 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
Additional details requested: was there any fragments observed within the iv bag? what brand iv bag/bottle was used? why was the spike removed? per response: 1.Not found.2.Terumo.3.I don't think it was missing.

• 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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24455047
• Report Number: 3003152976-2026-00105
• Device Sequence Number: 18634064
• Product Code: ONB
• UDI-Device Identifier: 00382905156281
• UDI-Public: (01)00382905156281(11)250721(17)270630(10)2507506
• 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): 04/27/2026

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: 2507506
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown