BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML BD LUER-LOK SYRINGE

    MDR report key: 11609246 · Received April 2, 2021

    Report

    Report Number
    1911916-2021-00282
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THE IMAGE OF THE SYRINGE TIP IS INCORRECT ON THE OUTSIDE OF THE BOX. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. IT COULD BE POSSIBLE THAT THE CUSTOMER IS UNFAMILIAR WITH THE DRAWING ON THE CASE BOX LABEL. THERE IS ONE DRAWING FOR ALL TYPE OF SYRINGE LUER TIP BOXES. BASED ON THE INVESTIGATION WITH NO RETURNED SAMPLE OR PHOTO ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOT NUMBER 0031484. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: IT COULD BE POSSIBLE THAT THE CUSTOMER IS CONFUSED WITH THE DRAWING IN OUR CASE LABEL. WE HAVE ONE DRAWING FOR ALL TYPE OF SYRINGE LUER TIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 650 20 ML BD LUER-LOK¿ SYRINGES EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301031 BATCH NO.: 0031484. WHILE PERFORMING THE INCOMING INSPECTION ON THIS BATCH, THE INSPECTOR FOUND THAT THE DIAGRAM OF THE SYRINGE TIP IS INCORRECT ON THE OUTSIDE OF THE BOX. THE OUTSIDE LABEL ON THE BOXES HAD AN IMAGE OF A LUER SLIP TIP SYRINGE BUT THIS PRODUCT IS A LUER LOCK TIP SYRINGE. THE VENDOR PART NUMBER AND THE SYRINGE (20ML LUER LOCK) INSIDE ARE BOTH CORRECT FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506491 20 ML BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0031484

    Patients

    Seq Age Sex Outcome Treatment
    1