BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 11656261 · Received April 13, 2021

    Report

    Report Number
    1911916-2021-00306
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 2, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 0163209 WAS PROVIDED BY THE INITIAL REPORTER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 0163029. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHYSICAL SAMPLE AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CAME IN A SEALED PACKAGING BLISTER AND A VISUAL INSPECTION WAS PERFORMED. THE SAMPLE HAS A SCALE PRINTING ISSUE. THE STOPPER HAS NO DAMAGES OR IMPERFECTIONS, BUT THE BARREL DOES HAVE A SCRATCH AT THE BOTTOM. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. IT COULD BE POSSIBLE THE CUSTOMER WAS CONFUSED WITH THE DAMAGE AT THE BOTTOM PART OF THE SYRINGE BARREL. INSTEAD THEY MAY HAVE THOUGHT THERE WAS SOMETHING WRONG WITH THE RUBBER STOPPER. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE AND PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. IT COULD BE POSSIBLE THAT THE CUSTOMER GOT CONFUSED WITH THE DAMAGE AT THE BOTTOM PART OF THE BARREL, BELIEVING THAT THERE WAS SOMETHING WRONG WITH THE RUBBER STOPPER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 30ML LL S/C 56 EXPERIENCED A DEFECTIVE/DAMAGED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POOR PLUNGER ROD STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554000 SYRINGE 30ML LL S/C 56 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1