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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
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 the bd phaseal¿ y-site connector (c80) experienced leakage.The following information was provided by the initial reporter: "we had leakage inside the white adapter piece of the c80.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 25-jul-2022.H6: investigation summary two unused samples and two photos were provided to our quality team for investigation.Through visual inspection of the photos, fluid is observed around the membrane, verifying the reported issue.Upon evaluation of the returned products, no damage or defects were observed on the devices and the membrane was verified to be properly welded on to the connector.Functional testing was performed, penetrating the membrane ten times and observing the product for any leakage.In all cases, the product functioned as intended and no leaks occurred.A device history review was performed for the reported lot 2108205, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including leakage and pressure testing for all lots to ensure the quality of the membrane.No issues related to the reported event were found during manufacturing.Based on the quality team's investigation, and given the returned samples and device records did not identify any issues related to this incident, a root cause related to the manufacturing process cannot be identified at this time.H3 other text : see h10.
Event or Problem Description
It was reported that the bd phaseal¿ y-site connector (c80) experienced leakage.The following information was provided by the initial reporter: "we had leakage inside the white adapter piece of the c80.".

• 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
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15164211
• Report Number: 3003152976-2022-00348
• Device Sequence Number: 17322729
• Product Code: ONB
• UDI-Device Identifier: 30382905153045
• UDI-Public: 30382905153045
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 515304
• Device Catalogue Number: 515304
• Device Lot Number: 2108205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown