BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11691106 · Received April 19, 2021

    Report

    Report Number
    3003152976-2021-00208
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 22, 2021
    Report Date
    May 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/5/2021. H.6 INVESTIGATION: ONE PHOTO AND ONE PHYSICAL SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A CRACK ALONG THE BARREL CAN BE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2010069, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE CRACKS ON THE BARRELS MAY HAVE OCCURRED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. GIVEN THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ISSUES RELATED TO THIS, WE CANNOT VERIFY THIS TO BE TRUE FOR THIS INCIDENT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER (PHARMACY OF THE (B)(6) HOSPITAL) HAS RECEIVED A COMPLAINT ABOUT A CRACK IN A BD SYRINGE 50 ML. THIS SYRINGE WAS PREPARED IN THE PHARMACY ON 15-03, DELIVERED TO THE ICU ON 16-03 AND ON 19-03 THEY RECEIVED A REPORT ABOUT A CRACK IN THE SYRINGE. IT SEEMS THAT THE CRACK WAS CREATED AFTER PREPARATION AND DELIVERY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE 50ML LL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER (PHARMACY OF THE (B)(6) HOSPITAL) HAS RECEIVED A COMPLAINT ABOUT A CRACK IN A BD SYRINGE 50 ML. THIS SYRINGE WAS PREPARED IN THE PHARMACY ON 15-03, DELIVERED TO THE ICU ON 16-03 AND ON 19-03 THEY RECEIVED A REPORT ABOUT A CRACK IN THE SYRINGE. IT SEEMS THAT THE CRACK WAS CREATED AFTER PREPARATION AND DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581328 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2010069

    Patients

    Seq Age Sex Outcome Treatment
    1