BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/O DN

    MDR report key: 9239580 · Received October 25, 2019

    Report

    Report Number
    1213809-2019-01070
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 31, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 1ML SYRINGE WITH A NEEDLE ATTACHED AND CLEAR LIQUID INSIDE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A BROWNISH FOREIGN MATTER PARTICLE INSIDE THE SYRINGE. IT APPEARED TO BE A CARDBOARD FRAGMENT AND WAS LARGER THAN LEVEL 2 IN SIZE WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING PROCESS. THERE IS A MANUFACTURING LINE IN THE AREA THAT OCCASIONALLY USES CARDBOARD BOXES TO FILL ORDERS. IT IS POSSIBLE A SMALL FIBER BROKE OFF ONE OF THE BOXES AND MADE IT ONTO THE LINE THAT PRODUCED THE 1ML SYRINGE. THE AQL FOR FOREIGN MATTER IN THE FLUID PATH IS 0.25%. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF (B)(4) WHICH IS (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9003925 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LL W/O DN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 9003925. THE REPORTER CONTACTED TO REQUEST FOR A REPLACEMENT OF ONE VIAL OF EYLEA. THE REPORTER STATED THAT AFTER THE OPERATOR DREW UP A DOSE OF EYLEA INTO THE SYRINGE, THE OPERATOR NOTICED A FOREIGN PARTICLE WAS FLOATING INSIDE THE SYRINGE. AS A RESULT, THE DOSE WAS NOT USED. DATE OF OCCURRENCE WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE 1ML LL W/O DN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628. BATCH NO.: 9003925. THE REPORTER CONTACTED TO REQUEST FOR A REPLACEMENT OF ONE VIAL OF EYLEA. THE REPORTER STATED THAT AFTER THE OPERATOR DREW UP A DOSE OF EYLEA INTO THE SYRINGE, THE OPERATOR NOTICED A FOREIGN PARTICLE WAS FLOATING INSIDE THE SYRINGE. AS A RESULT, THE DOSE WAS NOT USED. DATE OF OCCURRENCE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037329 SYRINGE 1ML LL W/O DN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9003925 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other