MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C35; INTRAVASCULAR ADMINISTRATION SET

Model Number	515200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that leakage occurred during use with a connector luer lock c35.The following information was provided by the initial reporter, "the event took place during the manual administration of chemotherapy performed by the ist.It was impossible to adapt one syringe to both.The preparation service was called and comes to collect the defective product.The second syringe fit.Administration was carried out according to the protocol without incidents.When the syringe's removed, while the entire product was being administered, a quantity of the product escapes from the syringe (safety adapter) splashing onto the care trolley.The service manager was informed.The preparation service was informed of this.The syringe was kept in the service.Neither the patient nor the caregiver had direct contact with the cytotoxic product.".
Event or Problem Description
It was reported that leakage occurred during use with a connector luer lock c35.The following information was provided by the initial reporter, "the event took place during the manual administration of chemotherapy performed by the ist.It was impossible to adapt one syringe to both.The preparation service was called and comes to collect the defective product.The second syringe fit.Administration was carried out according to the protocol without incidents.When the syringe's removed, while the entire product was being administered, a quantity of the product escapes from the syringe (safety adapter) splashing onto the care trolley.The service manager was informed.The preparation service was informed of this.The syringe was kept in the service.Neither the patient nor the caregiver had direct contact with the cytotoxic product.".
Additional Manufacturer Narrative
H.6.Investigation summary no photos or physicals samples that display the reported issue were provided for investigation.A device history review was performed for reported lot 1905113, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of the same lot were used for additional evaluation.The samples were visually inspected, no damage or defects was observed on any of the connectors or luer connections.Functional testing was completed, solution was withdrawn from a vial, then connecting the syringe and injector to five of the sample connectors.In all cases the product functioned properly, liquid passed through the system without issue and no leakages were identified.Leakage testing was then performed on the five additional retained samples, using a sample injector to penetrate the connector membrane ten times.All results were found to be acceptable with no leaks identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: CONNECTOR LUER LOCK C35
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9512913
• Report Number: 3003152976-2019-00873
• Device Sequence Number: 2535349
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 1905113
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other