BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LS

    MDR report key: 10570937 · Received September 22, 2020

    Report

    Report Number
    8041187-2020-00601
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 1, 2020
    Report Date
    November 10, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-09-23 H6: INVESTIGATION SUMMARY THREE PHOTOS AND ONE SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WAS OPEN SEALING DUE TO THE BARREL TIP COMING OUT FROM THE PACKAGING AND A DAMAGED TOP WEB. A SIMULATION WAS CONDUCTED TO CREATE THE DEFECT CAUSED BY THE BLISTER DOWN IN-FEED NIPPING ROLLER. THE POSITION OF THE NIPPING ROLLER WAS ADJUSTED TO BE LOWER ON ONE SIDE TO CREATE THE DAMAGED PACKAGE. FROM THE SIMULATION, THE SIMULATED AND THE SAMPLE RETURNED ARE IDENTICAL. FROM THE INVESTIGATION, THE TEAM WAS ABLE TO CONFIRM THE CUSTOMER EXPERIENCE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE ACTUAL SAMPLE RETURNED, IT IS OBSERVED THAT THERE IS A COMPLETE HEAT SEAL MARK ON THE BOTTOM WEB. THEREFORE, THE POTENTIAL AREA FOR THE DEFECTS TO OCCUR IS AFTER THE PRIMARY PACKAGING PROCESS, WHERE THE ASSEMBLED SYRINGE HAS PACKED INTO THE TOP AND BOTTOM WEB AND FORMED THE SYRINGE BLISTER. AFTER THE REVIEWING THE PROCESS, THE POTENTIAL STATION COULD BE FROM THE SECONDARY PACKAGING MACHINE. WHEN THERE IS A CHANGING NEW ROLLS OF THE TOP WEB PAPER OR BOTTOM WEB FILM, THE PRODUCTION TECHNICIAN IS REQUIRED TO RE-LOAD THE SYRINGE BLISTER TO THE NIPPING STATION. THE PROBABLE ROOT CAUSE OF THE DEFECT COULD BE DUE TO THE BLISTER UNIT RUN ASIDE WHEN THE PRODUCTION TECHNICIAN LOADS THE SYRINGE BLISTER AT NIPPING STATION, WHICH EVENTUALLY CAUSES THE SYRINGE BLISTER TO SKEW TO ONE SIDE. AS THE BLISTER UNITS RUN ASIDE, IT WILL MISALIGN WITH THE BLISTER DOWN NIPPING ROLLER, THEREAFTER, WHEN THE NIPPING ROLLER NIPS, IT WILL CAUSE UNIT BLISTERS TO HAVE DAMAGED TOP WEB. WHEN THE UNIT BLISTER GETS DAMAGED, THE PACKAGE WILL BE CRAMPED, AND THE SYRINGE TIP FORCES THE SEALING TO OPEN. THE DAMAGED BLISTER WILL BE TRAPPED AT THE IN-FEED ROLLER AND RESULTS IN THE SUBSEQUENT BLISTERS TO JAM AT THE OUT-CHUTE TRAY, FROM THE PRIMARY PACKAGING MACHINE TO THE NIPPING STATION. THE MACHINE WILL BE STOPPED DUE TO NO PARTS FLOWING TO THE OUT-FEED ROLLER. THEN, THE PRODUCTION TECHNICIAN WILL REMOVE THE TRAPPED PARTS AND PERFORM LINE CLEARANCE. THIS DEFECT COULD HAVE BEEN AN ESCAPEES WHICH WAS FAILED TO BE REMOVED BY THE PRODUCTION TECHNICIAN FROM THE LINE. PROCEDURE REVISIONS AND RE-TRAINING WILL OCCUR TO PREVENT THIS FROM RE-OCCURRING. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LS PACKAGE WAS NOT SEALED PROPERLY. THIS OCCURRED ON 4 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGE DOES NOT SEAL PROPERLY UNTIL SYRINGE TIP CAME OUT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3 ML LS PACKAGE WAS NOT SEALED PROPERLY. THIS OCCURRED ON 4 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGE DOES NOT SEAL PROPERLY UNTIL SYRINGE TIP CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035468 SYRINGE 3ML LS SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9144748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other