BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE 20ML

    MDR report key: 12973271 · Received December 9, 2021

    Report

    Report Number
    1911916-2021-01251
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 12, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS LEAKAGE OUT OF THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE UNIT HAS TAPED TO IT A CONNECTOR. WHEN REMOVING THE CONNECTOR, THERE WAS WHAT APPEARS TO BE RESIDUES OF BLOOD ON THE CONNECTOR AND SYRINGE LUER TIP. TO PREVENT CONTAMINATION, NO FURTHER ANALYSIS WAS PERFORMED. DURING THE VISUAL INSPECTION, NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1113456. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS LEAKAGE OUT OF THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE UNIT HAS TAPED TO IT A CONNECTOR. WHEN REMOVING THE CONNECTOR, THERE WAS WHAT APPEARS TO BE RESIDUES OF BLOOD ON THE CONNECTOR AND SYRINGE LUER TIP. TO PREVENT CONTAMINATION, NO FURTHER ANALYSIS WAS PERFORMED. DURING THE VISUAL INSPECTION, NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1113456. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ SYRINGE 20ML THERE WAS LEAKAGE PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 'THERE WERE LEAKS FROM OUT OF THE PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ SYRINGE 20ML THERE WAS LEAKAGE PAST THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 'THERE WERE LEAKS FROM OUT OF THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869895 BD LUER-LOK¿ SYRINGE 20ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1113465 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown