BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML S/T 200 S/C

    MDR report key: 9310129 · Received November 12, 2019

    Report

    Report Number
    1213809-2019-01128
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 28, 2019
    Report Date
    January 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : THE FOLLOWING INVESTIGATION WAS CONDUCTED UNDER A RELATED COMPLAINT. TWO PHOTOS OF A LOOSE 10ML SYRINGE WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE IN THE PHOTOS HAD A MINIMAL AMOUNT OF SCALE MARKINGS PRESENT AND THE SCALE WAS ILLEGIBLE AND SKEWED. THE MISSING PRINT WAS REJECTABLE PER PRODUCT SPECIFICATION. MACHINE LOGS INDICATE THERE WERE PRINT ISSUES DURING THE MANUFACTURE OF BATCH 9142558. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT WAS LIKELY DUE TO A BARREL JAM AT THE MARKER CAUSING BARRELS TO BE FED INCORRECTLY. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9142558 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS PRINTED ON 2 SEPARATE SYRINGES 10ML S/T 200 S/C WERE INCORRECT AND PARTIALLY MISSING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED MATERIAL M728424B001 WITH INCORRECT PRINTING".

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. 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 SCALE MARKINGS PRINTED ON 2 SEPARATE SYRINGES 10ML S/T 200 S/C WERE INCORRECT AND PARTIALLY MISSING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED MATERIAL M728424B001 WITH INCORRECT PRINTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103241 SYRINGE 10ML S/T 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9142558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other