BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ SAFETY NEEDLE 27 G X 1/2 IN

    MDR report key: 6886794 · Received September 22, 2017

    Report

    Report Number
    1920898-2017-00193
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Date of Event
    August 29, 2017
    Report Date
    October 19, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CUSTOMER RETURNED PHOTOS OF A 1ML, 13MM, 27G BD SAFETYGLIDE ALLERGY SYRINGE FROM LOT # 6232784. CUSTOMER STATES THAT THE PLUNGER BROKE WHILE DRAWING. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED A BROKEN THUMB PRESS. FOR BROKEN PLUNGERS DRY BARRELS (INSUFFICIENT SILICONE) FROM THE PREP DIAL THAT RESULT FROM A SILICONE GUN NOT FIRING. INSUFFICIENT SILICONE LEADS TO DIFFICULTY EXERCISING THE PLUNGER, AND CAN THEREBY RESULT IN BROKEN PLUNGERS. PLUNGER SCREW JAMS THAT WOULD DAMAGE PLUNGERS, I.E., THEY BREAK OR BEND PLUNGERS BOWED PLUNGERS THAT DO NOT GET SEATED, AND GET BROKEN OFF AT THE DELRIN WHEEL CUSTOMER RETURNED PHOTOS OF THE SYRINGE FROM LOT # 6232784. CUSTOMER STATES THAT THE PLUNGER BROKE WHILE DRAWING. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED A BROKEN THUMB PRESS. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 6232784. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. 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 ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE NEEDLE/PLUNGER OF THE BD SAFETYGLIDE¿ SAFETY NEEDLE 27 G X 1/2 BROKE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668421 BD SAFETYGLIDE¿ SAFETY NEEDLE 27 G X 1/2 IN SAFETY SYRINGE W/NEEDLE MEG BD MEDICAL - DIABETES CARE 6232784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other