BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ HEPARIN SYRINGE 27G X 1/2IN 1ML

    MDR report key: 6963231 · Received October 19, 2017

    Report

    Report Number
    1920898-2017-00260
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 29, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF STOPPER DEFECTIVE / DAMAGED, NEEDLE HUB HOLDER, AND TIP CAP LOOSE WITH LOT #5181517 REGARDING ITEM #471492. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A LOOSE 1 ML, ½¿, 27G HEPARIN SYRINGE WITHOUT ANY PACKAGING. CUSTOMER STATES THAT THE FLANGE IS BROKEN, THE SYRINGE TIP IS DEFORMED, AND IMPERMEABILITY SYRINGE TIP; TIP-CAP. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED A BROKEN FLANGE ON THE BARREL. THE PHOTOS ALSO EXHIBITED THE CANNULA END OF THE SYRINGE WITHOUT THE SHIELD AND SLIGHT DAMAGE TO THE HUB. SEE ATTACHED PHOTOS. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #5181517. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR ANY DEFECTS DURING THE PRODUCTION OF THESE BATCHES. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN FLANGE, MISSING SHIELD, DAMAGED HUB.) 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. A POSSIBLE ROOT CAUSE FOR A BROKEN FLANGE WAS NOTED TO BE THE BARREL LIKELY BEING BROKEN IN THE PREP DIAL PRIOR TO ASSEMBLY. POSSIBLE ROOT CAUSE FOR MISSING SHIELD AND SLIGHT HUB DAMAGE IS LIKELY DURING THE AUTO PACKAGING OPERATION THAT THE SHIELD COULD CATCH ON THE OUTSIDE OF THE CARTON AND WHEN THE PRODUCT TAMP STATION PRESSES THE AIR OUT OF THE BAGS THE SHIELD COULD BE REMOVED EXPOSING THE CANNULA. THIS WOULD LIKELY PROCEED THROUGH THE SYSTEM UNDETECTED UNLESS IT WAS DETECTED DURING HOURLY VISUAL INSPECTIONS FOR MISSING COMPONENTS. MANUFACTURING HAS NOT TAKEN ADDITIONAL STEPS FOR DETECTION OF THIS DEFECT AT THIS TIME. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BROKEN FLANGE, DEFORMED TIP AND LOOSE TIP WAS FOUND ON A BD¿ HEPARIN SYRINGE 27G X 1/2 IN 1 ML PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742962 BD¿ HEPARIN SYRINGE 27G X 1/2IN 1ML SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 5181517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other