MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD CONNECTOR LUER LOCK C45; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515202
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
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 after infusion, the chemo line and extension tubing was clamped.When disengaging the injector from the connector saline began to leak with a bd connector luer lock c45.The following information was provided by the initial reporter: it was reported that there was "leaking out from where the needle punctures through the membrane on the c45 onto the floor." patient was receiving a 24hr chemo.The infusion had a n35 on the end of the chemo tubing which was connected onto a c45 on the patient's kvo line at the lowest port on the kvo line.When the infusion was done, the rn clamped tubing on the chemo line, and clamped the extension tubing on the huber needle, then the rn disengaged the injector from the connector and waited a few seconds before completely removing the injector from the connector.The rn left the connector on as she would be hanging another 24hr chemo infusion.While getting the next chemo ready, the patient was standing up and i was in the room the whole time for the disconnection.I looked down and drops of saline from the kvo line were leaking out from where the needle punctures through the membrane on the c45 onto the floor.The rn removed that c45 and placed a new c45 onto the kvo line.
Additional Manufacturer Narrative
Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1903106, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Leakage testing was performed using the connector and a sample injector, no leaks were identified.Product is visually and functionally inspected throughout the manufacturing process to ensure the quality and functionality of the device.It is important to note that the performance of the sealing membrane is reduced after multiple perforations and extended activation time.Based on the available information we are not able to identity a root cause at his time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that after infusion, the chemo line and extension tubing was clamped.When disengaging the injector from the connector saline began to leak with a bd connector luer lock c45.The following information was provided by the initial reporter: it was reported that there was "leaking out from where the needle punctures through the membrane on the c45 onto the floor." patient was receiving a 24hr chemo.The infusion had a n35 on the end of the chemo tubing which was connected onto a c45 on the patient's kvo line at the lowest port on the kvo line.When the infusion was done, the rn clamped tubing on the chemo line, and clamped the extension tubing on the huber needle, then the rn disengaged the injector from the connector and waited a few seconds before completely removing the injector from the connector.The rn left the connector on as she would be hanging another 24hr chemo infusion.While getting the next chemo ready, the patient was standing up and i was in the room the whole time for the disconnection.I looked down and drops of saline from the kvo line were leaking out from where the needle punctures through the membrane on the c45 onto the floor.The rn removed that c45 and placed a new c45 onto the kvo line.

• Brand Name: BD CONNECTOR LUER LOCK C45
• 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: 8901516
• Report Number: 3003152976-2019-00556
• Device Sequence Number: 286123
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 02/28/2023
• Device Catalogue Number: 515202
• Device Lot Number: 1903106
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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