BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 12733812 · Received November 1, 2021

    Report

    Report Number
    1213809-2021-00738
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 4, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1097013. D4: MEDICAL DEVICE EXPIRATION DATE: 1203592. H4: DEVICE MANUFACTURE DATE: 2021-04-07. D4: MEDICAL DEVICE LOT #: 1159719. D4: MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. H4: DEVICE MANUFACTURE DATE: 2021-06-08. D4: MEDICAL DEVICE LOT #: 1203592. D4: MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. H4: DEVICE MANUFACTURE DATE: 2021-07-22. H6: INVESTIGATION SUMMARY : SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED AND THE COMPLAINT IS AN INQUIRY INTO PRODUCT ASSEMBLY ROOT CAUSE DETERMINATION AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS FOREIGN MATTER ON THE DEVICE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USING THE SYRINGES, WE NOTICED THERE IS SOME KIND OF MOISTURE ON THE PLUNGER. WE ASSUMED THAT IT COULD BE SILICONE OIL, BUT WE WERE NOT SURE AS WE COULD NOT FIND INDICATION ABOUT IT IN ANY OF THE PRODUCT DATA SHEETS/SPECIFICATIONS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS FOREIGN MATTER ON THE DEVICE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USING THE SYRINGES, WE NOTICED THERE IS SOME KIND OF MOISTURE ON THE PLUNGER. WE ASSUMED THAT IT COULD BE SILICONE OIL, BUT WE WERE NOT SURE AS WE COULD NOT FIND INDICATION ABOUT IT IN ANY OF THE PRODUCT DATA SHEETS/SPECIFICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629967 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 SEE H10 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown