BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10014866 · Received April 30, 2020

    Report

    Report Number
    1920898-2020-00445
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 10, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 8 MAY 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231251. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/13/2020. H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) SEALED POLYBAG FOR 31GX8MM, 1ML INSULIN SYRINGES FROM LOT 9231251. CONSUMER REPORTED: THE SYRINGE BAGS IN THIS BOX WERE CUT OPEN LOOKS LIKE WITH A RAZOR, THE SYRINGES PLUNGER CAPS LAYING IN THE BAGS, AND THE SYRINGE PLUNGERS OUT OF SYRINGE LAYING IN THE BAG OR EVEN MISSING. THE RETURNED POLYBAG WAS EXAMINED AND THE FOLLOWING WAS OBSERVED: - THE POLYBAG WAS DAMAGED - A BROKEN PLUNGER CAP WAS LOOSE INSIDE THE POLYBAG - A BROKEN PLUNGER ROD WAS LOOSE INSIDE THE POLYBAG - 10 SYRINGES WITH NO APPARENT DEFECTS A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231251. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DAMAGED POLYBAG, BROKEN PLUNGER CAP, BROKEN PLUNGER ROD) - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING PLUNGER ROD) PROCESS SUMMARY: A DIAL TRANSFERS THE CORRECT NUMBER OF SYRINGES TO A TUBE WHERE THEY DROP BY GRAVITY THROUGH THE TUBE COMING TO REST ON TOP OF THE POLYBAG SEALING JAWS. THE POLYBAG IS FORMED BY WEB THAT IS WRAPPED AROUND A METAL TUBE WHERE THE SIDES OF THE WEB OVERLAP AND ARE SEALED TO FORM THE VERTICAL SEAL. SEALING JAWS FORM THE POLYBAG BOTTOM, AS WELL AS THE TOP OF THE PREVIOUS POLYBAG. BETWEEN THE SEALING JAWS IS A KNIFE THAT SEVERS THE BAG FROM THE ROLL. THE BAGS ARE THEN CONVEYED TO BE HAND PACKED INTO ERECTED CARTONS. THE CARTONS ARE THEN CLOSED AND PLACED ON THE OUTFEED CONVEYOR TO BE LOADED INTO CASES AND PALLETIZED. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THIS DEFECT. THE DHR WAS REVIEWED AND NOTHING PERTAINING TO THE DEFECT WAS FOUND. A ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING WAS CUT AND STERILITY WAS COMPROMISED AS WELL AS PLUNGERS SEPARATED WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGE POLYBAGS WERE CUT. ALSO REPORTED PLUNGER CAPS LAYING IN BAGS AND SOME SYRINGE PLUNGERS WERE LAYING IN THE BAG OR EVEN MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING WAS CUT AND STERILITY WAS COMPROMISED AS WELL AS PLUNGERS SEPARATED WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGE POLYBAGS WERE CUT. ALSO REPORTED PLUNGER CAPS LAYING IN BAGS AND SOME SYRINGE PLUNGERS WERE LAYING IN THE BAG OR EVEN MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 PACKAGING WAS CUT AND STERILITY WAS COMPROMISED AS WELL AS PLUNGERS SEPARATED WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGE POLYBAGS WERE CUT. ALSO REPORTED PLUNGER CAPS LAYING IN BAGS AND SOME SYRINGE PLUNGERS WERE LAYING IN THE BAG OR EVEN MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476294 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328506 9231251 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other