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	11/28/2024
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
In pharmacy during preparing a cytostatic dose (sandoxan), they found a drop of liguid in the adapters membrane (after drug was inserted to iv-bag).No harm to patient or hcp (they saw the drop and avoided contact to that).Leakage from adapters membrane (cytostatics).During use.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: one used infusion adapter and injector was provided to our quality team for investigation.Through initial evaluation, it is noted the membrane of the adapter and injector has a glossy appearance, which may be silicone.There was no damage or other defects 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 a leak was observed.Leakage testing was performed, penetrating the adapter membrane ten times with the returned injector.In all cases the product functioned as intended and no leakage was observed.The membranes where disconnected for further evaluation and verified there was no excess of silicone, which can give the membrane a glossier appearance and be mistaken for drug leakage.A device history review was performed for infusion adapter lot 2407502, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for adapter lot 2407502, 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.The performance of the sealing membrane is reduced after multiple perforations and extended activation time, the membranes are designed to be punctured up to ten times.Based on the sample evaluation and quality team's investigation, we cannot identify a root cause related to our process at this time.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: 20836310
• Report Number: 3003152976-2024-00625
• Device Sequence Number: 14493074
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784(11)240731(17)260630(10)2407502
• 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): 01/30/2025

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: 06/30/2026
• Device Catalogue Number: 515078
• Device Lot Number: 2407502
• 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: 11/28/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown