BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8358121 · Received February 21, 2019

    Report

    Report Number
    1920898-2019-00195
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    February 4, 2019
    Report Date
    March 20, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) LOOSE 0.5ML 31G 8MM BD SYRINGES. CUSTOMER STATES THAT THEY FOUND IN THIS BOX PLUNGER MISSING ANOTHER PLUNGER THUMB PRESS MISSING. ALL RETURNED SYRINGES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 8 SYRINGES WITH CAP, SHIELD, AND PLUNGERS ATTACHED. 1 SYRINGE WITH SHIELD AND PLUNGER ATTACHED, NO CAP ATTACHED. 1 SYRINGE WITH SHIELD AND PLUNGER ATTACHED, NO CAP ATTACHED, BROKEN THUMB PRESS. 1 LOOSE DAMAGED CAP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8120882. ALL INSPECTIONS AND CHALLENGES 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 AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING PLUNGER ROD). CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING THUMB PRESS). 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. PROBABLE ROOT CAUSES: FOR BROKEN/BENT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE PLUNGER WAS MISSING FROM ONE SYRINGE AND ANOTHER PLUNGERS THUMB PRESS BROKE OFF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION SUMMARY : NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8120882. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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. ROOT CAUSE DESCRIPTION : ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE PLUNGER WAS MISSING FROM ONE SYRINGE AND ANOTHER PLUNGERS THUMB PRESS BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150396 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8120882 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other