BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE

    MDR report key: 7375626 · Received March 27, 2018

    Report

    Report Number
    1920898-2018-00206
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 20, 2018
    Report Date
    May 21, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282784
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1CC, 12.7MM, 30G SYRINGE IN AN OPEN POLY BAG FROM LOT#: 6123861. CUSTOMER STATES THAT THE BARREL IS CRACKED AND THEY ARE GETTING BUBBLES. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A CRACK IN THE BARREL RUNNING FROM APPROXIMATELY THE 32-52 UNIT MARKINGS. A CRACKED BARREL COULD CAUSE AIR BUBBLES WHEN ATTEMPTING TO DRAW. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON (B)(6) 2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON 17APR2018, HOLDREGE RECEIVED ONE (1) 1ML, 12.7MM, 30G SYRINGE IN OPENED POLYBAG FROM BATCH#: 6123861. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. PROBABLE ROOT CAUSE LIKELY TO BE A JAM ON THE FORM FILL & SEAL (FFS) DURING PACKAGING OF SYRINGES INTO THE POLYBAGS. WHEN THIS OCCURS, ANY PORTION OF THE SYRINGE OR COMPONENT MAY BE INVOLVED IN THE JAM AND UNDERGO VARYING DEGREES OF DAMAGE. THE SUBSEQUENTLY DAMAGED DEVICE IS CAPABLE OF STILL MAKING IT INTO THE POLYBAG AND ON TO THE CONSUMER WITHOUT DETECTION. GENERALLY, DAMAGE CAUSED DURING A JAW JAM RENDERS THE DEVICE INOPERABLE BY THE CONSUMER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 6123861 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200645768] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DAMAGED/CRACKED BARREL AND THE 1ST RELATED COMPLAINT FOR AIR BUBBLES ON LOT#: 6123861. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CRACKED BARREL AND AIR BUBBLES). POSSIBLE ROOT CAUSES: 1. DEFECT COULD HAVE OCCURRED AT THE PREP DIAL OF THE METRO ASSEMBLY MACHINE. LOSS OF BACK PRESSURE ON THE IN-FEED RAIL MAY CAUSE THE BARREL TO BECOME PINCHED AT THE RAIL / PREP DIAL JUNCTION. THE TRIP GATE EYE SENSOR SHOULD DETECT LOW RAIL CONDITIONS AND ACTIVATE THE TRIP GATE TO PREVENT THE BARRELS FROM BEING LOADED INTO THE PREP DIAL AND POSSIBLY JAMMING AT THAT LOCATION. 2. INFEED DIAL AT BARREL PRINTERS. 3. LOSS OF BACK PRESSURE AT INFEED RAIL ALSO AT FORM FILL & SEAL. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 BEFORE USE OF THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE THE BARREL ON THE SYRINGE WAS BROKEN. ¿WHEN DRAWING MEDICATION BUBBLES WERE SEEN.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215972 BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6123861 00382903282784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other