BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY NAC-Y SITE (0.143 TUBING) OEM

    MDR report key: 10242488 · Received July 7, 2020

    Report

    Report Number
    9616066-2020-02121
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 11, 2020
    Report Date
    June 11, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    PMA / PMN Number
    K962893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 06/23/2020. INVESTIGATION CONCLUSION: A VIDEO AND SAMPLE WAS PROVIDED. THE CUSTOMER COMPLAINT OF LEAKAGE FROM THE Y-PORT WAS CONFIRMED FROM THE VIDEO AND THE PICTURE. THE Y-SITE PISTON ISSUE OBSERVED IS UNIQUE AND HAS NOT BEEN DOCUMENTED AS A KNOWN ISSUE. SINCE A SAMPLE WAS NOT RETURNED THE ROOT CAUSE OF THE STOPPER DAMAGE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 19125907 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON (B)(6) 2019. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED: BD PRODUCT MODEL: 8100-028 REPORTED LOT NUMBER: 19098286 *NO QN¿S DURING THIS LOT MANUFACTURING. ONE SAMPLE OF THE 8100-028 WAS RECEIVED, VISUAL INSPECTION WAS PERFORMED IN THE SAMPLE. DURING VISUAL INSPECTION, IT WAS OBSERVED THAT THE VALVE IS IN A LOWER POSITION WHERE IT SHOULD BE. SINCE IT WAS CONFIRMED THAT THE VALVE IS IN A LOWER POSITION, A REVISION WITH THE MFT WAS CONDUCTED, THE SAMPLES WAS OPENED TO INSPECT THE VALVE. DURING THE VALVE INSPECTION A COMPARATION BETWEEN A VALVE IN PRODUCTION AND THE SAMPLE¿S VALVE, CONFIRMED THE SHORT SHOT FAILURE MODE. SINCE THE SHORT SHOT IN THE VALVE TC10008292 WAS CONFIRMED, A REVISION OF THE PROCESS WAS CONDUCTED, AND IT WAS FOUND THAT THE SAMPLE HAD THE VALVE CAVITY NUMBER OF 24D RELATED TO A CAVITY FROM SUPPLIER. THE ISSUE WAS ESCALATED TO THE VALVE SUPPLIER. THE SUPPLIER INSPECTED AND REPLACES THE VALVE GATES AND INJECTION TIPS IN THE MOLD TO AVOID THE SHORT SHOT ISSUE ON (B)(6) 2020, 5 MONTHS AFTER THE MANUFACTURING OF THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ASSEMBLY NAC-Y SITE (0.143 TUBING) OEM STOPPER WAS DAMAGED AND THE VALVE WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 8100-028; BATCH NO (LOT NO): 19098286. IT WAS REPORTED THE VALVE WAS LEAKING. WE FOUND THAT THERE WAS A LEAK IN THE POSITION OF THE STOPPER OF THE Y-SITE DURING THE SIMULATED INFUSION TEST. FROM THE APPEARANCE OF Y-SITE, THE LEAKAGE OF THE Y-SITE IS CAUSED BY THE DAMAGED OF THE STOPPER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASSEMBLY NAC-Y SITE (0.143 TUBING) OEM STOPPER WAS DAMAGED AND THE VALVE WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 8100-028 BATCH NO (LOT NO): 19098286. IT WAS REPORTED THE VALVE WAS LEAKING. WE FOUND THAT THERE WAS A LEAK IN THE POSITION OF THE STOPPER OF THE Y-SITE DURING THE SIMULATED INFUSION TEST. FROM THE APPEARANCE OF Y-SITE, THE LEAKAGE OF THE Y-SITE IS CAUSED BY THE DAMAGED OF THE STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704837 ASSEMBLY NAC-Y SITE (0.143 TUBING) OEM INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV 8100-028 19098286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other