BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II INSULIN SYRINGE

    MDR report key: 10156103 · Received June 15, 2020

    Report

    Report Number
    1920898-2020-00676
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 5, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR THUMBPRESS BROKEN ON LOT # 9161946. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, THUMBPRESS BROKEN) WAS CAPTURED AND ADDRESSED APPROPRIATELY INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 1/2CC SYRINGES. CUSTOMER STATES THAT THE WING WAS BROKEN WHEN THE CUSTOMER REMOVE PLUNGER CAP. THE PHOTO WAS EXAMINED AND EXHIBITED A BROKEN FLANGE. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161946. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THIS COMPLAINT. INVESTIGATION CONCLUSION: 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. 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. ROOT CAUSE DESCRIPTION: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD 1617317, "ON 10JUN2020, (B)(4) RECEIVED A COMPLAINT FOR DAMAGE/FLANGE BROKEN. VISUAL INSPECTION OF THE PICTURES FOUND (1) SYRINGE WITH ONE SIDE OF THE BARREL FLANGE BROKEN OFF PRINTER PROCESS SUMMARY: PROCESS SUMMARY: BLANK BARRELS ARE TRANSFERRED FROM TOTES TO A BULK HOPPER, THE HOPPER THEN METERS THEM INTO THE VIBRATORY FEEDER WHICH ORIENTS AND TRANSFERS THE BARRELS SINGLE FILE INTO THE FIRST INLINE FEEDER. THE FIRST INLINE FEEDER RAIL TRANSFERS TO THE INSPECTION DIAL WHERE SHORT MOLDING DEFECTS ARE REJECTED. AFTER THE INSPECTION DIAL, THE BARRELS ARE TRANSFERRED TO THE SECOND INLINE FEEDER AND TRANSITIONS THROUGH THE CORONA TREATER TERMINATING AT THE INHIBIT GATE. AT CYCLE START, THE INHIBIT GATE OPENS, INTRODUCING BARRELS TO PRINTER INFEED DIAL ON THROUGH THE FLANGE GUIDE WHICH ALIGNS THE FLANGES FOR PROPER REGISTRATION AND INTO THE PRINT CAROUSEL WHERE INK IMAGES ARE APPLIED. FROM THE PRINT CAROUSEL, THE BARRELS ARE TRANSITIONED TO THE TRANSFER DIAL AND INTO THE CURING OVEN. THE CURED PRODUCT EXITS THE OVEN CHUTE FOR TRANSFER TO THE NEXT OPERATION. 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." RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ II INSULIN SYRINGE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WING WAS BROKEN WHEN THE CUSTOMER REMOVE PLUNGER CAP. (THE WING WAS NOT BROKEN STATE WHEN SHE TOOK OUT THE SYRINGE FROM THE PACKAGE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619977 BD ULTRA-FINE II INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 9161946

    Patients

    Seq Age Sex Outcome Treatment
    1 Other