MAUDE Adverse Event Report: BECTON DICKINSON, S.A. Y-SITE CONNECTOR C80; INTERVASCULAR ADMINISTRATION SET

Catalog Number	515304
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 three y-site connectors c80 experienced leakage at the y site connector during use.The following information was provided by the initial reporter: material no.: 515304, batch no.: unknown.Y-site leaked 3 separate times on both ends of connection.Taped and tightened but still leaked.
Additional Manufacturer Narrative
H.6.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.Bd was not able to duplicate or confirm the customer¿s indicated failure as no product code, batch, or sample was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.H3 other text : see section h.10.
Event or Problem Description
It was reported that three y-site connectors c80 experienced leakage at the y site connector during use.The following information was provided by the initial reporter: material no.: 515304, batch no.: unknown.Y-site leaked 3 separate times on both ends of connection.Taped and tightened but still leaked.

• Brand Name: Y-SITE CONNECTOR C80
• Common Device Name: INTERVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8761051
• Report Number: 3003152976-2019-00443
• Device Sequence Number: 19254925
• Product Code: ONB
• UDI-Device Identifier: 30382905153045
• UDI-Public: 30382905153045
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 07/18/2019

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: 515304
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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