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

Model Number	515304
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
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 the bd phaseal¿ y-site connector c80 leaked from the nozzle during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "leakage at the rince nozzle, it's recurring".
Additional Manufacturer Narrative
H.6.Investigation: two photos were provided to our quality team for investigation.Through visual inspection of the photos, no leakage can be observed.Four retained samples were evaluated, in all cases the product functioned as intended and no leakages were observed.Product undergoes both visual and functional testing throughout manufacturing to ensure the quality and functionality of the device.A device history review was performed for lot 1905101, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ y-site connector c80 leaked from the nozzle during use.The following information was provided by the initial reporter, translated from french to english: "leakage at the rince nozzle, it's recurring".

• Brand Name: BD PHASEAL Y-SITE CONNECTOR C80
• 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: 9694513
• Report Number: 3003152976-2020-00049
• Device Sequence Number: 14175761
• Product Code: ONB
• UDI-Device Identifier: 30382905153045
• UDI-Public: 30382905153045
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 515304
• Device Catalogue Number: 515304
• Device Lot Number: 1905101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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