BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE

    MDR report key: 10269440 · Received July 14, 2020

    Report

    Report Number
    1920898-2020-00838
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 22, 2020
    Report Date
    June 26, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048130
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. (B)(4). INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED 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# 9241004. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER CAP DAMAGED/HOLE, SHIELD DAMAGED/HOLE, PLUNGER ROD UNABLE TO MOVE, NEEDLE BENT AND NEEDLE DULL ON LOT # 9241004. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, PLUNGER CAP DAMAGED/HOLE, SHIELD DAMAGED/HOLE, PLUNGER ROD UNABLE TO MOVE, NEEDLE BENT AND NEEDLE DULL) WAS CAPTURED AND ADDRESSED APPROPRIATELY. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD SAFETYGLIDE¿ INSULIN SYRINGES HAD HOLES IN THEIR PLUNGER CAPS AND NEEDLE SHIELDS, AND 4 SYRINGES HAD DIFFICULT PLUNGER ROD MOVEMENT. ALL DEFECTS WERE NOTICED DURING USE IN LOT# 9241004. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THERE ARE HOLES IN THE PLUNGER CAP AND NEEDLE SHIELDS OF TWO SYRINGES. PLUNGER ROD WILL NOT MOVE, ASKED CONSUMER IF THE ROD WAS DIFFICULT TO MOVE AND HE SAID IT WILL NOT MOVE. NEEDLE WAS BENT WHEN SHIELD WAS REMOVED. NEEDLES DULL. ISSUES INVOLVE 4 SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733062 BD SAFETYGLIDE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928856 9241004 00311917048130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other