BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿INSULIN WITH SHORT NEEDLE

    MDR report key: 7510671 · Received May 14, 2018

    Report

    Report Number
    9614033-2018-00029
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    May 4, 2018
    Report Date
    June 15, 2018
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AS PER INVESTIGATION CARRIED OUT BY MANUFACTURING, "THE LOT: 7240686 WAS CONDITIONED IN THE MIDDLE OF THE MONTH OF APRIL 2018, IT HAS THE LINE CLEARANCE RIT0647CTIS05-11 WHICH IS DONE PER DAY AND PER SHIFT WHERE IT IS VERIFIED THAT THERE ARE NO BOXES, PRODUCT, LABELS, CORNERS OR ANY OTHER OBJECT THAT DOES NOT BELONG TO THE BATCH THAT IS GOING TO BE PROCESSED, ALL BEING IN CONFORMITY. ADDITIONAL IN THE PRODUCT CONDITIONING PROCESS IS MONITORED THROUGH THE RIT0647CTIS05-14 REV.01 FREQUENCY WHERE THEY EVALUATED ATTRIBUTES SUCH AS: INDIVIDUAL BOX CORRESPOND WITH PRODUCT (VISUAL METHOD INDIVIDUAL BOX VS PRODUCT INSIDE INDIVIDUAL BOX), CORRECT BATCH NUMBER IN INDIVIDUAL BOX (VISUAL METHOD INDIVIDUAL BOX VS BATCH PRINTED IN BLISTER OR BAG), CORRECT EXPIRATION DATE IN INDIVIDUAL BOX (VISUAL METHOD BOX INDIVIDUAL VS EXPIRATION DATE PRINTED ON BLISTER OR BAG), LEGIBLE AND CORRECT TEXTS IN INDIVIDUAL BOX AND BLISTER (VISUAL METHOD BOX INDIVIDUAL VS BLISTER OR BAG), CORRECT NUMBER OF SYRINGES OR NEEDLES FOR INSULIN IN INDIVIDUAL BOX (MANUAL PIECE COUNT METHOD), AMONG OTHERS; 26 PIECES PER HOUR IN INDIVIDUAL BOX AND 10 PIECES OF COLLECTIVE BOX WERE TAKEN, WITH A LIMIT OF ACCEPTANCE OF 0 AND REJECTION OF 1, NO NON-CONFORMING PIECES ARE REPORTED DURING THE CONDITIONING PROCESS. BOTH BATCHES WERE INSPECTED FOR QUALITY CONTROL BY EVALUATING THE CORRESPONDING INDIVIDUAL BOX WITH THE PRODUCT, CORRECT BATCH NUMBER IN INDIVIDUAL BOX, CORRECT EXPIRATION DATE IN INDIVIDUAL BOX, LEGIBLE TEXTS IN INDIVIDUAL BOX, CORRECT NUMBER OF SYRINGES, AMONG OTHER CHARACTERISTICS, BEING CONFORMED WITHIN THE AQL = 0.15% BASED ON THE SAMPLE TAKEN FROM 80 COLLECTIVE BOXES. IN THE INVESTIGATION REGARDING FAILURE MODES IT IS OBSERVED THAT IN THE DOCUMENTARY REVIEW OF LOT: 7240686 IT IS IDENTIFIED THAT 2 CODES ARE MADE (PRESENTATIONS) WITH THE SAME PRODUCT, CODE: 324013 THAT CORRESPONDS TO THE PRESENTATION BOX WITH 10 PIECES IS CONDITIONED IN MACHINE CECO 2 IN THE MONTHS OF JANUARY AND APRIL OF 2018 AND CODE: 326785 WHICH IS A BOX PRESENTATION WITH 30 PIECES WHICH IS MANUALLY CONDITIONED IN THE MONTHS OF APRIL 2018. LOT: 7268764 ONLY HAS THE BOX PRESENTATION WITH 30 PIECES CONDITIONED IN THE MONTHS OF FEBRUARY AND MARCH. IT IS WORTH MENTIONING THAT THE TRACEABILITY ACCORDING TO THE DOCUMENTARY REVIEW OF THE LOTS INVOLVED INDICATES THAT THEY DID NOT COHABIT OR WERE CONSECUTIVE; ADDITIONAL IT IS IMPORTANT TO MENTION THAT TO CONDITION THE PRODUCTS IN THE COLLECTIVE BOX BETWEEN BOTH PRESENTATIONS IS DIFFERENT, THAT IS TO SAY PRESENTATION BOX WITH 30 PIECES THE TOTAL CONTENT IS 450 PIECES AND THE PRESENTATION BOX WITH 10 PIECES TOTAL CONTENT IS 400 PIECES AS WELL AS THE SIZE OF THE BOXES ARE DIFFERENT SO THAT CONDITIONING WOULD NOT HAVE BEEN AVAILABLE. HOWEVER, FOR THE PHOTOGRAPHS SENT BY THE CLIENT, A HUMAN ERROR IN THE HANDLING OF THE CONDITIONING MATERIALS IS NOT RULED OUT, ALTHOUGH IN THE DOCUMENTARY REVIEW THERE IS NO CONVINCING EVIDENCE OF COEXISTENCE OR CONTINUOUS CONDITIONING BETWEEN BOTH LOTS, SO THE PROBABILITY OF HUMAN ERROR IS VERY LOW AND THIS WOULD BE A VERY SPECIFIC AND ISOLATED CASE SO FAR". BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿INSULIN WITH SHORT NEEDLE THERE WAS AN ISSUE WITH A LABELING ERROR. IT WAS STATED ¿IN THE BOX IS A CODE AND INTERNAL IS ANOTHER". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352727 BD ULTRA-FINE¿INSULIN WITH SHORT NEEDLE INSULIN SYRINGE AND NEEDLE FMI BECTON DICKINSON DE MEXICO 7268764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other