MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 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	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident and a root cause could be determined.A device history review could not be completed as no batch number was provided.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no lot information or sample was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Root cause description: no lot information or sample available.
Event or Problem Description
It was reported that the connector luer lock c45 experienced leakage during use.The following information was provided by the initial reporter: material no.: 515202, batch no.: unknown.Per email: leaking noted at connection between phaseal and needle phaseal luer lock connector.

• Brand Name: 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: 9157387
• Report Number: 3003152976-2019-00693
• Device Sequence Number: 19372365
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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: Other
• Device Catalogue Number: 515202
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/04/2019
• 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