BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 9386736 · Received November 27, 2019

    Report

    Report Number
    1920898-2019-01351
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8092781. CUSTOMER STATES THAT THERE IS A BROKEN LID. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN THUMB PRESS ON THE PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # (B)(4) ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: "ON (B)(6) 2019, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE. VISUAL INSPECTION OF THE PICTURE FOUND (1) SYRINGE WITH DAMAGE TO THE PLUNGER THUMBPRESS. THE THUMBPRESS IS COMPLETELY BROKEN OFF THE END OF THE PLUNGER ROD. THE PLUNGER ROD ALSO APPEARS TO HAVE DAMAGE JUST BELOW WHERE THE THUMBPRESS WOULD BE ATTACHED. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.3ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. L2L DISPATCH #66353 WAS CREATED DURING THE CREATION OF THIS BATCH FOR BENT PLUNGERS. ROOT CAUSE WAS DEBRIS WAS UNDER THE PART CARRIERS CAUSING THE PLUNGER TO BEND. CORRECTION WAS TO CLEAN THE DEBRIS OUT OF THE PART CARRIERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BREAKAGE WAS FOUND BEFORE USE WITH A SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BROKEN LID. SYRINGE USER (A CAREGIVER) FOUND A BROKEN LID OF INSULIN SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182467 BD ULTRA-FINE PEN NEEDLE SYRINGE FMF BD MEDICAL - DIABETES CARE 8092781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other