BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.3ML 31GX6MM U-100 INSULIN SYRINGE

    MDR report key: 9355470 · Received November 21, 2019

    Report

    Report Number
    1920898-2019-01312
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 3, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED TWO (2) 31GX6MM, 0.3ML RELION INSULIN SYRINGES FROM AN OPENED POLYBAG FROM LOT 9133810. RELION CONSUMER REPORTED, WHEN SHE REMOVED THE SHIELD, NEEDLE HUB SEPARATED. THE RETURNED SAMPLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: ONE SYRINGE THAT EXHIBITED NEEDLE-HUB/SHIELD SEPARATION; NO DAMAGE TO THE BARREL TIP. ONE SYRINGE THAT EXHIBITED NEEDLE-HUB/SHIELD SEPARATION; BROKEN BARREL TIP. ONE SEPARATED NEEDLE-HUB/SHIELD ASSEMBLY WITH A BROKEN BARREL TIP; A SYRINGE BARREL WAS NOT RETURNED WITH THIS HUB ASSEMBLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9133810. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200827854] NOTED FOR CRACKED HUBS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES, BROKEN BARREL TIP). AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 26 NOV 2019, HOLDREGE RECEIVED PHOTO COMPLAINT. A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLY ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, 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. ROOT CAUSE: L2L DISPATCH #69176 WAS CREATED FOR RAISED SHIELDS. THERE WAS DEBRIS IN THE DIAL. CORRECTIVE ACTION: THE DEBRIS WAS CLEANED OUT OF THE DIAL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. TIP-2019-37 WAS IMPLEMENTED ON 10JUL2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA1122103 HAS BEEN OPENED TO ADDRESS THIS ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 0.3ML 31GX6MM U-100 INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328521 BATCH NO: 9133810 . VERBATIM: CONSUMER REPORTED, WHEN SHE REMOVED THE SHIELD, NEEDLE HUB SEPARATED. 5 SYRINGES AFFECTED COULD NOT USE THEM PROVIDED, 1 INCIDENT DATE: 2019-11-03 INCIDENT DATE UNKNOWN FOR THE 4 ADDITIONAL SYRINGES ALL 5 SYRINGES FROM SAME BOX LOT: 9133810 ITEM: 31G, 3/10 ML, 6MM, 328521.

    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 5 0.3ML 31GX6MM U-100 INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328521 BATCH NO: 9133810. VERBATIM: CONSUMER REPORTED, WHEN SHE REMOVED THE SHIELD, NEEDLE HUB SEPARATED. 5 SYRINGES AFFECTED, COULD NOT USE THEM PROVIDED, 1 INCIDENT DATE: (B)(6) 2019. INCIDENT DATE UNKNOWN FOR THE 4 ADDITIONAL SYRINGES. ALL 5 SYRINGES FROM SAME BOX. LOT: 9133810. ITEM: 31G, 3/10 ML, 6MM, 328521.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154023 0.3ML 31GX6MM U-100 INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9133810 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other