MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD CONNECTOR C35-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515070
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd connector c35-o had a disconnection at the luer lock.The following information was provided by the initial reporter: verbatim: customer states that during a home infusion the connector "blew off of the extension set" seemingly from a build up of pressure.A clamp was in place, and while still connected to the injector, the connector blew off the tubing with force that caused the clamp to open, and the tubing swing up and hit the patient in the face.This resulted in a chemo spill as the fluid pathway was still open and the patient did not receive their entire dose.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two photos were provided to our quality team for investigation.Upon evaluation, the connector is observed inside the infusion clamp, disconnected from the injector and mating tubing.There is no visible damage or other defect identified within the photos to indicate why the connection may have separated.The product undergoes routine visual and functional testing throughout the manufacturing process to ensure quality and proper device performance, including verification that all critical dimensions meet specification.Because the lot number associated with this incident was not available, a device history review could not be completed.Based on the available information, we were unable to identify a root cause linked to the manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD CONNECTOR C35-O
• 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: 24338095
• Report Number: 3003152976-2026-00071
• Device Sequence Number: 9799183
• Product Code: ONB
• UDI-Device Identifier: 00382905150708
• UDI-Public: (01)00382905150708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 515070
• Device Lot Number: UNKNOWN
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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