BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL 3ML LL WWD WITH SIL NO LOGO BNS

    MDR report key: 10248435 · Received July 8, 2020

    Report

    Report Number
    1213809-2020-00449
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: ONE PHOTO AND SIXTY-SEVEN LOOSE 3ML BARRELS WERE RECEIVED AND EVALUATED. IT WAS OBSERVED SIXTY-FOUR HAD A SINGLE SCRATCH OUTSIDE THE GRAD LINES AT THE 0.4ML GRAD LINE. TWO OF THE SIXTY-FOUR ALSO HAD SMALL PLASTIC FRAGMENTS EXTENDING FROM THE SCRATCH, WHICH WERE REJECTABLE PER PRODUCT SPECIFICATION. THREE OF THE BARRELS HAD MINOR SCUFFS IN THE SAME AREA. SIXTY-FIVE OF THE SIXTY-SEVEN TOTAL SAMPLES RECEIVED APPEARED TO HAVE MINOR SCRATCHES OR SCUFFS THAT WERE COSMETIC IN NATURE, WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH A QUALITY NOTIFICATION ISSUED FOR SCRAPES ON THE BARREL. BATCH 9211905 WAS INSPECTED, AND THE SCRATCHED BARRELS WERE ACCEPTED AS YELLOW CONDITION BASED ON THE DAMAGE CRITERIA AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE SCRATCHED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IN REGARDS TO THE CUSTOMERS QUESTION "IS THIS CONDITION NORMAL?", THE SCRAPES ARE NOT NORMAL AND ARE CONSIDERED A PRODUCT DEFECT. IN REGARDS TO THE QUESTION "IS THERE ANY RISK OF HAVING A LEAK DURING USE?", THE SITE'S RESPONSE IS ALSO, NO. NONE OF THE SAMPLES RECEIVED HAS SCRATCHES THAT PUNCTURED THE BARREL. MOST WERE COSMETIC JUST BELOW THE SURFACE OF THE BARREL THAT DID NOT AFFECT THE FORM, FIT OR FUNCTION OF THE DEVICE. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9211905 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5000 BARREL 3ML LL WWD WITH SIL NO LOGO BNS UNITS WERE FOUND WITH SCRATCHES/SLITS ON THE OUTER WALL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR PRODUCTION TEAM HAS FOUND UNITS WITH SCRATCHES/SLITS ON THE OUTSIDE WALL OF THE BARREL. THESE UNITS BELONG TO LOT: 9211905. AT THIS POINT WE HAVE FOUND 4 BAGS (5,000 EAS EACH) WITH UNITS AFFECTED WITH THIS CONDITION. THERE'S A HIGH POSSIBILITY THAT MATERIAL GETS ON HOLD AND INTERRUPT PRODUCTION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5000 BARREL 3ML LL WWD WITH SIL NO LOGO BNS UNITS WERE FOUND WITH SCRATCHES/SLITS ON THE OUTER WALL BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR PRODUCTION TEAM HAS FOUND UNITS WITH SCRATCHES/SLITS ON THE OUTSIDE WALL OF THE BARREL. THESE UNITS BELONG TO LOT: 9211905. AT THIS POINT WE HAVE FOUND 4 BAGS (5,000 EAS EACH) WITH UNITS AFFECTED WITH THIS CONDITION. THERE'S A HIGH POSSIBILITY THAT MATERIAL GETS ON HOLD AND INTERRUPTS PRODUCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712746 BARREL 3ML LL WWD WITH SIL NO LOGO BNS SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9211905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other