BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 8851331 · Received August 1, 2019

    Report

    Report Number
    1213809-2019-00797
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 5ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE IN THE PHOTO WAS MISSING GRAD LINE ABOVE THE 4ML MARKING AS WELL AS THE "D" FROM THE BD LOGO. THE AMOUNT OF MISSING PRINT IS REJECTABLE PER PRODUCT SPECIFICATION. A PHYSICAL SAMPLE IS NEEDED FOR A MORE THOROUGH INVESTIGATION. IT IS UNCLEAR IN THE PHOTO PROVIDED IF THE PRINT WAS SCRATCHED OFF OR APPLIED INCORRECTLY. 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. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9122848 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE SCALE MARKING WERE NOT LEGIBLE WITH A BD SYRINGE 5ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: GRADUATION OF THE SYRINGE + BD LABELLING ARE NOT LEGIBLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 PRIOR TO USE IT WAS DISCOVERED THAT THE SCALE MARKING WERE NOT LEGIBLE WITH A BD SYRINGE 5ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GRADUATION OF THE SYRINGE + BD LABELLING ARE NOT LEGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647730 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9122848

    Patients

    Seq Age Sex Outcome Treatment
    1 Other