BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE

    MDR report key: 11828812 · Received May 14, 2021

    Report

    Report Number
    1920898-2021-00556
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048130
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CUSTOMER RETURNED A TOTAL OF 14 SYRINGES AND A POUCH LABELED FOR 1.0ML, 31 GAUGE, 8MM SYRINGES FROM LOT 0232158. EACH SAMPLE WAS INSPECTED TO ENSURE THAT USING THE SYRINGE WAS AS LEAST HARMFUL AS INTENDED. HOWEVER, DURING VISUAL INSPECTION, ADHESIVE WAS FOUND ALONG THE OUTER DIAMETER OF ALL OF THE NEEDLE CANNULAS. THE CLEAR, RUBBERY DROPS FOUND ON EACH NEEDLE MADE IT DIFFICULT TO MEASURE THE NEEDLES¿ DIAMETERS. THE NEEDLES WERE INSPECTED UNDER UV LIGHT TO CONFIRM THAT THE SUBSTANCE FOUND WAS INDEED ADHESIVE USED TO FASTEN THE SYRINGE¿S COMPONENTS TOGETHER. NO OTHER DEFECTS WERE FOUND DURING INSPECTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0232158. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200893686] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF BLUNT NEEDLES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. ON (B)(6) 2021, HOLDREGE RECEIVED A PHOTO COMPLAINT SAMPLE FOR ADHESIVE SPLATTER ON SYRINGE 1.0ML 31GA 8MM, BATCH: 0232158 AND CATALOG NUMBER: 928856. VISUAL INSPECTION OF THE PICTURE FOUND SPLATTER OF ADHESIVE ON THE CANNULA ON MULTIPLE SYRINGES. PROCESS SUMMARY: THIS OPERATION ASSEMBLES THE CANNULA INTO THE BARREL TIP AND APPLIES ADHESIVE TO HOLD THE CANNULA IN THE BARREL TIP. THE RACKS OF CANNULATED BARRELS THEN TRAVEL THROUGH AN OVEN WHICH USES IR LIGHT TO FACILITATE ADHESIVE RUN DOWN AND ULTRAVIOLET LIGHT TO CURE THE ADHESIVE THAT BONDS THE CANNULA TO THE BARREL TIP. THE CANNULATED BARRELS ARE THEN CONVEYED TO A MACHINE THAT INSPECTS FOR MISSING CANNULA, CANNULA HEIGHT, POINT QUALITY, ZERO LINE PLACEMENT, AND UV ADHESIVE. IT ALSO SUPPLIES LUBE TO THE CANNULA, FEATURES TWO LUMEN BLOWS, ASSEMBLES THE SHIELD TO THE BARREL/CANNULA ASSEMBLY, AND DETECTS FOR MISSING SHIELDS. REVIEWED L2L MAINTENANCE LOGS, LOG BOOKS AND IF ANY MACHINE CHANGES OCCURS, DID NOT IDENTIFY ANY CHANGES. THERE WAS ONE (1) NOTIFICATION [200893686] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THEREFORE, COULD NOT DETERMINE A ROOT-CAUSE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXCESSIVE ADHESIVE WAS FOUND ON THE BD INSULIN SYRINGE NEEDLE DURING THE INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLES DULL, NOT SMOOTH AND WILL NOT PENETRATE THE SKIN." VIA BD INVESTIGATION: "CUSTOMER RETURNED A TOTAL OF 14 SYRINGES AND A POUCH LABELED FOR 1.0ML, 31 GAUGE, 8MM SYRINGES FROM LOT 0232158. EACH SAMPLE WAS INSPECTED TO ENSURE THAT USING THE SYRINGE WAS AS LEAST HARMFUL AS INTENDED. HOWEVER, DURING VISUAL INSPECTION, ADHESIVE WAS FOUND ALONG THE OUTER DIAMETER OF ALL OF THE NEEDLE CANNULAS. THE CLEAR, RUBBERY DROPS FOUND ON EACH NEEDLE MADE IT DIFFICULT TO MEASURE THE NEEDLES¿ DIAMETERS. THE NEEDLES WERE INSPECTED UNDER UV LIGHT TO CONFIRM THAT THE SUBSTANCE FOUND WAS INDEED ADHESIVE USED TO FASTEN THE SYRINGE¿S COMPONENTS TOGETHER. NO OTHER DEFECTS WERE FOUND DURING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720774 BD INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928856 0232158 00311917048130

    Patients

    Seq Age Sex Outcome Treatment
    1