BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 9069837 · Received September 16, 2019

    Report

    Report Number
    1920898-2019-00992
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 30, 2019
    Report Date
    September 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) 29G X 12.7MM, 1ML BD INSULIN SYRINGE SEALED IN A BLISTER PACK FROM LOT 8141660. CONSUMER REPORTED THE NEEDLE WAS PROTRUDING THROUGH THE SAFETY CAP. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE CANNULA WAS PIERCED THROUGH THE CANNULA SHIELD AND BLISTER PACK. THE CAUSE OF THIS ISSUE LIKELY OCCURRED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8141660. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 16SEP2019, HOLDREGE RECEIVED A COMPLAINT, VIA PICTURES, FROM MATERIAL 326719, BATCH 8141660. VISUAL INSPECTION OF THE PICTURES FOUND THE CANNULA PIERCED THROUGH THE SIDE OF THE SHIELD HORIZONTALLY. THE TIP OF THE CANNULA WAS STICKING OUT THROUGH THE PLASTIC OF THE BLISTER BOTTOM WEB. PROCESS SUMMARY: THIS MACHINE 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. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES THAT PERTAINED TO THIS DEFECT DURING THE TIMEFRAME OF THE PRODUCTION OF THIS SYRINGE. ROOT CAUSE CANNOT BE DETERMINED. THIS BATCH WAS MADE BEFORE IMPLEMENTATION OF CAPA 529089 WHICH ADDRESSED NEEDLE THROUGH SHIELD. 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 · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE PIERCED THROUGH THE SAFETY CAP. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE WA AIDS COUNCIL THAT A CLIENT IDENTIFIED 3 EXAMPLES WHERE THE NEEDLE WAS PROTRUDING THROUGH THE SAFETY CAP. TWO PACKAGES WERE RETURNED OPENED, SO WERE DISPOSED OF, BUT ONE SEALED PACK WAS ALSO RETURNED, SHOWING THE PROTRUDING NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE PIERCED THROUGH THE SAFETY CAP. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE WA AIDS COUNCIL THAT A CLIENT IDENTIFIED 3 EXAMPLES WHERE THE NEEDLE WAS PROTRUDING THROUGH THE SAFETY CAP. TWO PACKAGES WERE RETURNED OPENED, SO WERE DISPOSED OF, BUT ONE SEALED PACK WAS ALSO RETURNED, SHOWING THE PROTRUDING NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866635 BD ULTRA-FINE INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 8141660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other