BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10038940 · Received May 8, 2020

    Report

    Report Number
    1213809-2020-00297
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Date of Event
    April 27, 2020
    Report Date
    April 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. (B)(6). INVESTIGATION SUMMARY: NO PHYSICAL SAMPLE RECEIVED, ONE PHOTO WAS RECEIVED FOR INVESTIGATION. ONE PHOTO OF THE BOTTOM HALF OF TWO LOOSE 1ML SYRINGES WAS RECEIVED AND EVALUATED. IT WAS OBSERVED ONE OF THE SYRINGES HAD THE SCALE SHIFTED UPWARDS AWAY FROM THE COLLAR APPROXIMATELY 0.04ML, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL PHOTOS AND/OR SAMPLES TO DISPLAY THE ENTIRE SYRINGE WITH NO ADDITIONAL EVIDENCE RECEIVED. 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: 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. ROOT CAUSE DESCRIPTION: THE POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PHOTO PROVIDED. A PHYSICAL SAMPLE OR PHOTOS DISPLAYING THE ENTIRE SYRINGE ARE NECESSARY FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. RATIONALE: CORRECTIVE ACTIONS CANNOT BE PERFORMED AS THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 1ML SYRINGE LUER-LOK¿ TIP HAD SCALE MARKING ISSUES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309628, BATCH NO: 9051802. IT WAS REPORTED THAT VOLUME MEASUREMENTS ARE NOT CORRECTLY PRINTED ON THE SYRINGE. COMPLAINT DESCRIPTION A SYRINGE TAKEN FROM AN EYLEA BOX TODAY WAS NOT CORRECTLY PRINTED WITH THE VOLUME MEASUREMENTS. THE ABNORMAL SYRINGE IS ON THE LEFT AND A NORMAL SYRINGE IS ON THE RIGHT FOR COMPARISON. OBVIOUSLY IF INJECTING PHYSICIANS ARE NOT CAREFUL THIS MIS-LABELING COULD LEAD TO AN OVERDOSE AND IOP SPIKE. AFTER THE PHYSICIAN NOTED THE PROBLEM WITH THE SYRINGE PROVIDED IN THE KIT, THE PHYSICIAN CHOSE NOT TO USE THAT SYRINGE AND THEN SUCCESSFULLY USED A SYRINGE FROM HIS OWN OFFICE SUPPLY TO ADMINISTER THE DOSE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504571 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9051802 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other