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

Catalog Number	515078
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Description/event details: during cyclofosfamide preparation they found a drop of liquid in c-100-o ;after injector detached from membrane.In pharmacy clean room area during cyclofosfamide dose preparation, pharmasist detached a injector (used only once) from adapter c-100-o and they realized a drop of liquid in the membrane (adapter).Pharmasist tested that drop with with their hd check cyc test kit, and the result was positive from that test.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one photo and one infusion adapter assembled with an iv bag, was provided to our quality team for investigation.Through visual evaluation of the photo, the membrane appears shiny, but it cannot be verified if there was liquid on the membrane.The physical sample was inspected, no damage or other defects were observed on the product to indicate if or why a leakage may have occurred.Functional testing was performed, liquid was passed through the system and no evidence of any leak was identified.Upon disengaging an injector from the infusion adapter, no evidence of fluid or any leak was found on the membrane.A device history review was performed for adapter lot 2409504, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for lot 2409504, and all results were found to be acceptable.Three retained samples of the reported lot were used for additional evaluation.The membranes were punctured up to ten times, in all cases the product functioned as intended and no leakages occurred.Based on the sample evaluation and quality team's investigation, we cannot identify a root cause related to our process at this time.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: INFUSION ADAPTER C100-O
• 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: 21445512
• Report Number: 3003152976-2025-00064
• Device Sequence Number: 7967994
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784(11)240930(17)260831(10)2409504
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K181221
• 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): 05/27/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 515078
• Device Lot Number: 2409504
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown