BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7667894 · Received July 6, 2018

    Report

    Report Number
    1213809-2018-00400
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 14, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, BD WAS UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED NO DEFECTS COULD BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE DEFECTIVE GRADUATION MARKS ON MANY BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE DEFECTIVE GRADUATION MARKS ON MANY BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8001666; MEDICAL DEVICE EXPIRATION DATE: 12/31/2022; DEVICE MANUFACTURE DATE: 01/16/2018; MEDICAL DEVICE LOT #: 8001668; MEDICAL DEVICE EXPIRATION DATE: 12/31/2022; DEVICE MANUFACTURE DATE: 01/16/2018. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE DEFECTIVE GRADUATION MARKS ON MANY BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510268 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other