BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MEDICAL (BD WEST) MEDICAL SURGICAL

    MDR report key: 12063025 · Received June 24, 2021

    Report

    Report Number
    1911916-2021-00596
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/14/2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 CASES OF BD MEDICAL (BD WEST) MEDICAL SURGICAL WERE FOUND TO HAVE FOREIGN MATTER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER RECEIVED 4 CASE DEFECTIVE/CONTAMINATED ON (B)(4), LOT 1084398 & 1091352. ON THE INSIDE AND ON THE WRAPPED TUBE HAS BLACK MARKS,SMEARS. WE APPRECIATE YOUR BUSINESS. PLEASE CONTACT US AGAIN IF WE CAN HELP YOU WITH ANYTHING IN THE FUTURE."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED BY THE DISTRIBUTOR THAT ON THE INSIDE AND ON THE WRAPPED TUBE THERE ARE BLACK MARKS AND SMEARS. TO AID IN THE INVESTIGATION, TWO HUNDRED EIGHTY SAMPLES IN SEALED PACKAGING BLISTERS AND FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED ON THE SAMPLES RECEIVED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE FOUR PHOTOS PROVIDED SHOW SYRINGES WITH WHAT APPEARS TO BE EMBEDDED DEGRADED RESIN AND SMEAR PRINTING. IN ORDER TO CONFIRM THIS THE ACTUAL SAMPLES WOULD BE NEEDED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 1084398. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE ACTUAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 CASES OF BD MEDICAL (BD WEST) MEDICAL SURGICAL WERE FOUND TO HAVE FOREIGN MATTER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER RECEIVED 4 CASE DEFECTIVE/CONTAMINATED ON PR2480004, LOT 1084398 & 1091352. ON THE INSIDE AND ON THE WRAPPED TUBE HAS BLACK MARKS,SMEARS. WE APPRECIATE YOUR BUSINESS. PLEASE CONTACT US AGAIN IF WE CAN HELP YOU WITH ANYTHING IN THE FUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953084 BD MEDICAL (BD WEST) MEDICAL SURGICAL PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 1084398 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1