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	10/21/2025
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: the nss bag was seen leaking from the head section of the infusion adapter c100.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: three photos and a video sample were provided to our quality team for investigation.Upon visual evaluation, leakage through the adapter port was observed, confirming the reported concern.A device history review was conducted for lot 2411207.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.Leakage testing was performed by attaching the infusion adapters to an iv bag filled with liquid and applying pressure based on the available information, and without a physical sample from the reported incident for further evaluation, a definitive root cause cannot be identified at this 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
Event details: the nss bag was seen leaking from the head section of the infusion adapter c100 after discussing with the customer, it was confirmed that the septum had not been punctured.

• 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: 23426852
• Report Number: 3003152976-2025-00611
• Device Sequence Number: 18548278
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: (01)00382905153068(11)241118(17)281031(10)2411207
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• 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: Health Professional
• Device Catalogue Number: 515306
• Device Lot Number: 2411207
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown