BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 12391912 · Received August 31, 2021

    Report

    Report Number
    1911916-2021-00896
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 2, 2021
    Report Date
    August 20, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE SYRINGE DID NOT HAVE ANY NUMBERS OR MARKINGS. TO AID IN THE INVESTIGATION, THREE SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE SCALE PRINTING IS MISSING ON THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS A PACKAGING BLISTER WITH A SYRINGE THAT APPEARS TO HAVE NO SCALE MARKING. FROM THE PHOTO IT IS DIFFICULT TO BE CERTAIN, THE SCALE MARKING COULD BE AT THE BOTTOM SIDE OF THE SYRINGE AND MAY NOT BE SEEN. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE PRINTING PROCESS INDUCING THE MISSING SCALE MARKINGS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1113409. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE. IT COULD BE POSSIBLE THAT THE PRINTING DRUM GOT MISALIGNED INDUCING THE SCALE PRINTING MISSING. VERIFICATION OF THE SYRINGE PRINTING PROCESS WAS PERFORMED. SETTINGS WERE CORRECT, PRINTING PAD WAS PROPERLY ADJUSTED. FLOW OF PRODUCTS WAS GOOD. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 20ML LL S/C 48 WAS MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE SYRINGE DID NOT HAVE ANY NUMBERS OR MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300318 SYRINGE 20ML LL S/C 48 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1113409 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1