BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL BRAZIL

    MDR report key: 12724371 · Received October 29, 2021

    Report

    Report Number
    1911916-2021-01122
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-11-15 H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A BLACK FRAGMENT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE LUER LOK HAS AN EMBEDDED BLACK SPECK. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT NUMBER 1103477. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO MITIGATE THESE ESCAPES, THE FREQUENCY OF INSPECTIONS WERE INCREASED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 50ML LL BRAZIL CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRTY SYRINGE (BLACK FRAGMENT).".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SYRINGE 50ML LL BRAZIL CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRTY SYRINGE (BLACK FRAGMENT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618269 BD SYRINGE 50ML LL BRAZIL PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1103477

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown