BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 12709778 · Received October 28, 2021

    Report

    Report Number
    1213809-2021-00729
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 29, 2021
    Report Date
    January 14, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT DATE OF MANUFACTURING ON CARTON LABEL WAS DIFFERENT THAT DATE OF MANUFACTURING ON SHELF PACK LABEL. DATE OF MANUFACTURING ON CARTON LABEL WAS (B)(6) 2021 WHILE DATE OF MANUFACTURING ON SHELF PACK LABEL WAS (B)(6) 2020. IT SHOULD BE 2021 ON SHELF PACK LABEL RATHER THAN 2020. POTENTIAL ROOT CAUSE FOR LABEL CONTENT INCORRECT ON SHELF PACK IS ASSOCIATED WITH OPERATOR ERROR FROM TWO SUPPLIERS. THE FOLLOWING CORRECTIVE ACTIONS HAS BEEN TAKEN BY SUPPLIERS IN RESPONSE TO THIS COMPLAINT: 1. DEVELOPED PRINTING SYSTEM WHICH SUPPORT TO IMPORT INFORMATION AUTOMATICALLY. RETRAINED OPERATOR AND INSPECTORS . 2. UPDATED PROCESS TO ADD THE CHECK REQUIREMENT ON DIFFERENT LABEL LEVEL. RETAINED OPERATORS AND INSPECTORS. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1082604.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS INCORRECT LABEL INFORMATION ON THE DEVICE. THIS EVENT AFFECTED (B)(4)DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "DISTRIBUTOR FOUND (B)(4) BOXES OF DISPOSABLE STERILE SYRINGES WHERE THE PRODUCTION DATES OF THE INNER PACKAGING AND THE OUTER PACKAGING WERE INCONSISTENT. A BOX OF (B)(4) PIECES, A TOTAL OF (B)(4) PIECES AFFECTED.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS INCORRECT LABEL INFORMATION ON THE DEVICE. THIS EVENT AFFECTED 1600 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "DISTRIBUTOR FOUND TWO BOXES OF DISPOSABLE STERILE SYRINGES WHERE THE PRODUCTION DATES OF THE INNER PACKAGING AND THE OUTER PACKAGING WERE INCONSISTENT. A BOX OF 800 PIECES, A TOTAL OF 1600 PIECES AFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608712 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 1082604 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown