BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15581563 · Received October 11, 2022

    Report

    Report Number
    9610847-2022-00393
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 19, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903056171
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2153333. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027. DEVICE MANUFACTURE DATE: 10-JUN-2022. MEDICAL DEVICE LOT #: 2090624. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. DEVICE MANUFACTURE DATE: 28-APR-2022. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SCALE MARKING ISSUES WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO. THE PHOTO DID NOT CLEARLY DISPLAY THE REPORTED DEFECT. A PHYSICAL SAMPLE IS NEEDED TO CONFIRM THE DEFECT REPORTED. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. DHR FOR BOTH LOTS WERE REVIEWED AND THERE ARE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ TIP SYRINGES EXPERIENCED MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME SYRINGES HAVE MISPRINTED GRADATIONS THAT WE HAD USED IN A BATCH COMPOUND. THE SYRINGE MARKINGS ARE NOT STRAIGHT ON THE SYRINGE AND THEY ALSO EXTEND PAST THE BARREL OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378353 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 305617 SEE H10 30382903056171

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown