BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL EUROGRAPHICS

    MDR report key: 11646271 · Received April 9, 2021

    Report

    Report Number
    1213809-2021-00219
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 24, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903009121
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D10: RETURNED TO MANUFACTURER ON: 2021-04-05. H6: INVESTIGATION SUMMARY: ONE LOOSE 10ML SYRINGE AND THE TOP WEB OF A BLISTER PACK FROM BATCH 0310201 (P/N 300912) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WERE THREE SMALL BROWN EMBEDDED FOREIGN MATTER PARTICLES PRESENT ON THE TIP AND COLLAR OF THE SYRINGE. THE PARTICLES APPEARED TO BE BURNT PLASTIC AND WERE LARGER IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0310201 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL EUROGRAPHICS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE PACKAGING, WE NOTICED BROWN STAINS AT THE LEVEL OF THE SCREWTHREAD OF THE SYRINGE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL (B)(6) HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE PACKAGING, WE NOTICED BROWN STAINS AT THE LEVEL OF THE SCREWTHREAD OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542995 SYRINGE 10ML LL EUROGRAPHICS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0310201 00382903009121

    Patients

    Seq Age Sex Outcome Treatment
    1