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

Catalog Number	515304
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ y-site connector (c80) was leaking.The following was received by the initital reporter: verbatim: clinicians have reported that the y-site connector are leaking- several reports made.This product is used for bcg treatment and needs to be a closed system.The leaking is noted at the bottom (male leur-lock end) that attaches closest to the catheter photos supplied as the item was discarded.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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) was leaking.The following was received by the initital reporter: verbatim: clinicians have reported that the y-site connector are leaking - several reports made.This product is used for bcg treatment and needs to be a closed system.The leaking is noted at the bottom (male leur-lock end) that attaches closest to the catheter photos supplied as the item was discarded.
Additional Manufacturer Narrative
Two photos were provided to our quality for evaluation.Through visual inspection, the material information is displayed, however, there is no evidence of a leak or damage to the device that could contribute to the leak reported.A device history review was performed for the reported lot 2202228, 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.No issues related to the reported event were found during manufacturing.Retained samples of the same lot were used for additional evaluation.The products were visually inspected, no damage was observed and no leakages occurred.Based on the quality team's investigation, and given the retained 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.

• Brand Name: BD PHASEAL¿ Y-SITE CONNECTOR (C80)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17477324
• Report Number: 3002682307-2023-00228
• Device Sequence Number: 2736057
• Product Code: ONB
• UDI-Device Identifier: 00382905153044
• UDI-Public: (01)00382905153044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 515304
• Device Lot Number: 2202228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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