BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE

    MDR report key: 8280034 · Received January 25, 2019

    Report

    Report Number
    1920898-2019-00109
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1/2CC BD SAFETYGLIDE INSULIN SYRINGE. CUSTOMER STATES THAT THE BARREL BROKE WHILE ASPIRATING MEDICATION. THE RETURNED SYRINGE WAS RETURNED WITH THE HUB-NEEDLE-SAFETY MECHANISM/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARREL WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8171730. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / 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. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. UPON VISUAL EVALUATION, SIMILAR FINDINGS TO THOSE DOUCMENTED BY BD FRANKLIN LAKES INITAL INVESTIGATION. THE NEEDLE ASSEMBLY WITH SHIELD WAS SEPARATED FROM BARREL. INSPECTION OF THE BARREL TIP SHOWED NO SIGNS OF DAMAGE. NEEDLE ASSEMBLY WAS ABLE TO BE REMOVED FROM SHIELD AND THE HUB WAS INSPECTED, DAMAGE WAS FOUND ON THE INSIDE OF THE HUB CORE. PROBABLE ROOT CAUSE FOR HUB SEPARATES, HUB CORE DAMAGE COULD CAUSE THE HUB NOT TO BE ATTACHED TO THE BARREL, CAUSING HUB SEPARATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ SAFETY SYRINGES HAD A BROKEN BARREL DISCOVERED DURING USE.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED NUMBER OF BD¿ SAFETY SYRINGES HAD A BROKEN BARREL DISCOVERED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69907 BD SAFETYGLIDE INSULIN SYRINGE INSULIN SYRINGE MEG BD MEDICAL - DIABETES CARE 8171730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other