MAUDE Adverse Event Report: BECTON DICKINSON INFUSION ADAPTER C100; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515306
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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 is reported leakage.Event description: the medication was seen leaking from the head section of the infusion adapter c100.
Event or Problem Description
It is reported leakage.Event description: the medication was seen leaking from the head section of the infusion adapter c100.In description it was mentioned as "the medication was seen leaking from the head section of the infusion adapter c100".Kindly confirm if there is any patient injury happened.The patient did not sustain any injury as the issue occurred before administering medication to the patient.Please follow up to verify the specific location of the leak: the connection interface.Are they referring to the spike? not the spike.Was the leak through the membrane? unknown.Was is where the tubing connects? not connected to the tubing; the leakage occurred before connection.
Additional Manufacturer Narrative
(b)(6) follow up mdr for device evaluation: three photos and one sample has been provided to our quality team for investigation.Upon visual inspection, it was observed that the membrane was missing, therefore the system was open and leaked when used, verifying the reported concern.A device history review was performed for lot 2411207; no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.A detection system is used to verify the proper welding and location of the membrane.All quality records verify the inspections were performed according to procedure and product met required specifications for release.While we cannot identify a direct issue, it was determined this incident is due to an error during assembly and the detection system also not identifying/rejecting the impacted piece.Manufacturing personnel have been notified of this incident.Complaints received for this device and reported condition will continue to be tracked and trended for signs of emerging trends.

• Brand Name: INFUSION ADAPTER C100
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 22809020
• Report Number: 3003152976-2025-00447
• Device Sequence Number: 15665180
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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