MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INFUSION ADAPTER C100-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515078
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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: customer is spiking bags with the optima infusion adaptor (c100-o) and has seen a plastic particle from the entry point go up into the bag.This has happened with both an empty bag and a 250 ml saline bag mixed with a hazardous drug.Customer is concerned about the small plastic piece entering the bag.Per customer response 24oct2025: the floating plastic piece appears like a clear air bubble, it was found on physical inspection of a chemo bag.However, you can tell it¿s actually plastic because it can¿t be dispersed and is hard when you press down on it.This occurred with both of these products at our system: ¿ (b)(4) of baxter intravia container, empty.150ml capacity.¿ bbraun 250ml ns, lot j5d844, exp 03/2027.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that a plastic piece was observed floating inside an iv bag.Two c100-o infusion adapters and the associated iv bags were provided to the quality team for evaluation.During inspection, the intravia container 150 ml capacity baxter bag was found to contain the plastic particle; no particles were observed in the second iv bag.Because the plastic piece could not be safely extracted, characterization testing could not be performed.However, the membrane of the iv bag was found to be ruptured at the location where the spike is inserted into the bag.Dimensional testing showed that the diameter of the iv bag port was smaller than the diameter of the spike.As a result, excessive force was required to insert the c100-o adapter, which caused the port membrane to rupture and generated the plastic fragment observed inside the bag.A device history review was completed for lot 2412502, and no deviations or nonconformances related to the reported issue were identified during the manufacturing process.All products undergo multiple inspections throughout production to ensure quality and functionality, including verification that all critical dimensions are within specification.The results for the reported lot were reviewed and confirmed to be within the required limits.Based on our investigation and the evaluation of the returned samples, we could not identify a root cause related to the product or manufacturing process.Our findings indicate that the plastic piece likely broke off due to compatibility issues between the adapter and the iv bag.Specifically, the port on the iv bag was smaller in diameter than the c100-o infusion adapter, which would require greater force during insertion and could lead to damage as observed on the samples provided.We appreciate you bringing this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and monitored for any signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INFUSION ADAPTER C100-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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23413354
• Report Number: 3003152976-2025-00588
• Device Sequence Number: 8945410
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784(11)250102(17)261130(10)2412502
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/28/2026

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: 515078
• Device Lot Number: 2412502
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown