BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7643717 · Received June 27, 2018

    Report

    Report Number
    1920898-2018-00493
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    June 5, 2018
    Report Date
    July 25, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF BD SAFETYGLIDE INSULIN SYRINGES IN SEALED BLISTER PACKS FROM LOT#: 8002686. CUSTOMER STATES THAT THEY ORDERED TWO CASES OF PRODUCT: 305932; HOWEVER, THE CUSTOMER RECEIVED ONE BOX OF 305932 AND ONE BOX OF 305930, YET THE CONTENTS IN BOTH BOXES ARE 305932. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED SYRINGES IN SEALED BLISTER PACKS MARKED AS BD SAFETYGLIDE INSULIN SYRINGES 1/2ML, 13MM, 29G, CAT#: 305932, LOT#: 8002686. ALSO SHOWN IN THE PHOTOS IS A SHELF CARTON OF BD SAFETYGLIDE INSULIN SYRINGES 1ML, 13MM, 29G, CAT#: 305930, LOT#: 8002686. SITUATION ANALYSIS#: BDDC-18-1288 HAS BEEN OPENED TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 8002686. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. NOTE: WHILE DOING THE DHR REVIEW IT WAS OBSERVED THAT THE WRONG LABEL (CATALOG#: 305930) WAS FOUND TO BE IN WITH THE LABEL RETAINS OF CATALOG#: 305932. A ZM WAS WRITTEN [200753519]. THERE WERE TWO (2) NOTIFICATIONS [200735281, 200735618] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: CAPA: PR472475 AND SA BDDC-18-1288 WERE INITIATED BY THE HOLDREGE PLANT TO ADDRESS THIS LOT AND EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE A BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE WAS FOUND WITH A PACKAGING LABEL ERROR. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE A BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE WAS FOUND WITH A PACKAGING LABEL ERROR. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486417 BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE MEG BD MEDICAL - DIABETES CARE 8002686

    Patients

    Seq Age Sex Outcome Treatment
    1 Other