MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL; INFUSION ADAPTER (C100)

Catalog Number	515306
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event details: leakage from infusion bag, sample is available and cytotoxic.During use follow up response received on -12/31/2025.Please note that there was no patient or user harmed.Fluid that leaked contained doxorubicin, docetaxel.Follow up response received on -1/8/2026.Please confirm: was the infusion adapter fully inserted when the leakage occurred? answer: yes, it was fully inserted.Was there any damage noted on the infusion bag? answer: no what brand iv bag was used? answer: baxter.
Additional Manufacturer Narrative
Initial mdr, 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 photo, one video, and a physical sample were provided to our quality team for investigation.Upon reviewing the photo and video, liquid was observed on the exterior of the iv bag.A thorough inspection of the returned product identified no damage or defects that could have contributed to the reported leakage.Functional testing was performed by inserting the infusion adapter into an iv bag.Liquid was injected without issue, and pressure was applied to the bag.No leaks were detected from the adapter or any connection points.A device history review was conducted for lot 2404213.No deviations or nonconformances were identified during the manufacturing process that could have contributed to this observation.During the assembly process, an automated inspection is performed in which channels are leak-tested by passing airflow through them; parts that fail are automatically rejected.All quality records confirm that inspections were completed according to established procedures and that the product met all specifications for release.Additionally, three retained samples from the reported lot were evaluated.Visual inspection revealed no damage or defects in any of the infusion adapters and no leakages were identified.Based on the investigation and evaluation of the returned sample, no root cause related to the product or manufacturing process can be determined at this time.Complaints for this device and reported condition will continue to be monitored by our quality team for any signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD PHASEAL
• Common Device Name: INFUSION ADAPTER (C100)
• 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: 24088910
• Report Number: 3003152976-2026-00011
• Device Sequence Number: 5879339
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068(11)240424(17)280331(10)2404213
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K123213
• 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): 03/02/2026

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: Other
• Device Catalogue Number: 515306
• Device Lot Number: 2404213
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown