BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1213809-2018-00553

    MDR report key: 7805450 · Received August 22, 2018

    Report

    Report Number
    1213809-2018-00553
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 2, 2018
    Report Date
    September 6, 2018
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE 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 NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. INVESTIGATION CONCLUSION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. 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 THE BD LUER-LOK¿ TIP SYRINGES WITHOUT NEEDLES HAD ISSUES WITH FOREIGN MATTER CONTAMINATES, BARREL DAMAGES, INSECURE STOPPERS, AND MISALIGNED SCALE MARKINGS. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7150678, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-05-30. MEDICAL DEVICE LOT #: 7278957, MEDICAL DEVICE EXPIRATION DATE: 2022-09-30, DEVICE MANUFACTURE DATE: 2017-10-05. MEDICAL DEVICE LOT #: 7277752, MEDICAL DEVICE EXPIRATION DATE: 2022-09-30, DEVICE MANUFACTURE DATE: 2017-10-04. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGES WITHOUT NEEDLES HAD ISSUES WITH FOREIGN MATTER CONTAMINATES, BARREL DAMAGES, INSECURE STOPPERS, AND MISALIGNED SCALE MARKINGS. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other