BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV

    MDR report key: 7349427 · Received March 19, 2018

    Report

    Report Number
    1920898-2018-00167
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    March 5, 2018
    Report Date
    April 13, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294610
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED 34 1/2CC, 13MM, 28G BD INSULIN SYRINGES IN BLISTER PACKS WITH THE SHELF CARTON FROM LOT # 6172649. CUSTOMER STATES THAT THE PACKAGING WAS NOT SEALED. ALL RETURNED SYRINGES WERE EXAMINED AND 13 OUT OF 34 SAMPLES EXHIBITED A MISALIGNED TOP AND BOTTOM WEB CAUSING THE BLISTER PACK TO NOT BE SEALED CORRECTLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6172649. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSES INCLUDE: IT IS POSSIBLE DURING THE SEALING AND CUTTING PROCESS, THAT IF THE MACHINE IS STOPPED AND IS RUN IN ¿JOG¿ MODE, THE TOP AND BOTTOM WEB WILL NOT SEAL PROPERLY. THE VACUUM IN THE AUTOPACK ROBOT ARM CREATES ENOUGH SUCTION THAT IT PULLS AIR THROUGH THE PAPER TOP WEB AND PULLS THE SYRINGE AND PLASTIC BOTTOM WEB ENOUGH TO ALLOW THE BLISTER PACKAGE TO BE PACKED INTO THE CASES WITHOUT THE SYRINGES FALLING OUT. ONE MACHINE CYCLE JOGGED THROUGH THE MACHINE WOULD CREATE 30 OPEN PACKAGES WITH NO HEAT APPLIED AND WOULD BE PACKED INTO 6 DIFFERENT CASES. EACH CASE COULD HAVE UP TO 5 OPEN BLISTER PACKAGES IN THEM. IT¿S POSSIBLE THAT SOME OF THE PACKAGES DID NOT MAKE IT INTO THE CASES BECAUSE THE SYRINGES FELL OUT OF THE PACKAGES AT THE MACHINE DURING THE PROCESS OF THE ROBOT ARM PUTTING THEM INTO THE CASES. IT IS LIKELY THAT THE WEB BROKE WHILE THE MACHINE WAS RUNNING WHICH REQUIRED THE OPERATOR TO PUT THE MACHINE INTO JOG MODE TO GET THE WEB BACK INTO THE CORRECT SEQUENCE IN THE MACHINE. WHEN THIS OCCURS THERE ARE SYRINGES ALREADY IN THE POCKETS BEFORE THE SEAL PLATE. THE OPERATOR MUST ALSO FEED THE WEB BACK THROUGH THE MACHINE AFTER THE WEB BREAK. THIS COULD HAVE CAUSED THE PACKAGES TO HAVE OPEN SEALS ALONG THE LONG EDGE AS THE WEB WAS REALIGNED IN THE MACHINE. THE WEB ALIGNER EYES ADJUST THE WEB TO PREVENT IT FROM GETTING TOO FAR OUT OF ALIGNMENT HOWEVER AFTER A WEB BREAK THE FIRST FEW CYCLES MAY BE FAR ENOUGH OFF TO ALLOW OPEN SEALS.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT DURING USE A BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV PERMANENTLY ATTACHED NEEDLE WAS FOUND WITH A BREACH IN STERILE INTEGRITY. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194290 BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6172649 30382903294610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other