BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 8950779 · Received August 30, 2019

    Report

    Report Number
    1213809-2019-00879
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 1ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE IN THE PHOTO HAD A SKEWED SCALE THAT WRAPPED AROUND 1/4 OF THE BARREL. THIS WAS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE PHOTO PROVIDED. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE SKEWED SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. RATIONALE: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8220916 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE MARKINGS "TWISTED" AROUND THE BARREL OF THE BD SYRINGE LUER-LOK¿ TIP AND WERE NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON THE SYRINGE, A TWISTED SCALE WAS MARKED, WHICH CAN NOT BE CORRECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743973 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8220916 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other