BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 10475353 · Received August 31, 2020

    Report

    Report Number
    1213809-2020-00584
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 2, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A LOOSE 10ML SYRINGE WITH UNKNOWN STOPPER INSIDE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SCALE WAS SKEWED AND THE PRINT WAS MISSING FROM THE 5ML MARKING TO THE "ML" OF THE 10ML MARKING, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9210982 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SCALE MARKINGS ARE MISSING FROM THE LOWER HALF OF THE SYRINGE AND THE SCALE MARKINGS ARE DISTORTED ON THE UPPER HALF OF THE SYRINGE. ISSUE: IT WAS VISUALLY INSPECTED AND CONFIRMED THAT LOWER HALF PART OF SCALE IS NOT PRINTED ON THE SYRINGE. ADDITIONALLY, UPPER HALF PART OF SCALE IS DISTORTED.".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SCALE MARKINGS ARE MISSING FROM THE LOWER HALF OF THE SYRINGE AND THE SCALE MARKINGS ARE DISTORTED ON THE UPPER HALF OF THE SYRINGE. ISSUE: IT WAS VISUALLY INSPECTED AND CONFIRMED THAT LOWER HALF PART OF SCALE IS NOT PRINTED ON THE SYRINGE. ADDITIONALLY, UPPER HALF PART OF SCALE IS DISTORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939762 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9210982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other