BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II INSULIN SYRINGE

    MDR report key: 9318542 · Received November 13, 2019

    Report

    Report Number
    1920898-2019-01288
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 29, 2019
    Report Date
    October 30, 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
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9063775, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2019-03-04, MEDICAL DEVICE LOT #: 9014726, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-01-14. 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 MISSING LABEL CONTENT (NO LOT) ON LOT # 9063775. THIS IS THE 1ST RELATED COMPLAINT FOR SHELF CARTON DAMAGED/TORN ON LOT # 9014726. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS OF 1/2CC, 8MM, 30G BD SYRINGES FROM LOT # 9014726 AND PHOTOS OF SHELF CARTONS OF 1/2CC, 8MM, 30G BD SYRINGES FROM LOT # 9063775. CUSTOMER STATES THAT THERE IS NO LOT AND THE BOX IS TORN. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED A SHELF CARTON FROM LOT # 9014726 THAT WAS SHOWN TO BE TORN AND A SHELF CARTON FROM LOT # 9063775 THAT EXHIBITED MISSING LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE INFORMATION. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. 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 1270138, ON 06NOV2019, HOLDREGE RECEIVED A COMPLAINT, VIA PICTURES, FROM MATERIAL 326725, BATCHES 9014726 AND 9063775. VISUAL INSPECTION OF THE PICTURES FOUND A CARTON FROM BATCH 9014726 THAT WAS TORN ON THE BOTTOM, AND A CARTON FROM BATCH 9063775 WITH THE LOT CODE, MANUFACTURING DATE, AND EXPIRATION DATE MISSING. PROCESS SUMMARY: THE BLISTERPACK MACHINE PACKAGES THE SYRINGES INTO A SEQUENCE OF INDIVIDUALLY FORMED POCKETS IN THE BOTTOM WEB THAT IS HEAT-SEALED WITH THE TOP WEB AND THEN CUT INTO INDIVIDUAL BLISTERS. SEALED BLISTERS ARE THEN CONVEYED AND PICKED AND PLACED INTO A SHELF CARTON. FINISHED CARTONS ARE THEN CONVEYED ACROSS A SCALE TO ENSURE THAT THE CORRECT AMOUNT OF SYRINGES HAVE BEEN PLACED IN THE CARTONS AND THEN ARE CONVEYED TO THE CASE PACK. ONCE FIVE CARTONS ARE IN POSITION, A CASE IS ERECTED AND THE FIVE CARTONS ARE SHUTTLED INTO THE ERECTED CASE. THE CASE THEN IS TAPED CLOSED AND TRANSFERRED TO THE PELLETIZER SYSTEM WHERE THEY ARE LABELED AND PLACED ON THE PALLET. THERE WERE NO NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE TIMEFRAME OF THIS BATCH THAT PERTAIN TO THIS DEFECT. ROOT CAUSE FOR THIS DEFECT 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 HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ II INSULIN SYRINGE HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LOT 9063775 NO LOT = 2 SP, LOT 9014726 TORE BOX = 1 SP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108419 BD ULTRA-FINE II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other