BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10751915 · Received October 28, 2020

    Report

    Report Number
    1920898-2020-01488
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 8, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (3) LOOSE 1/2CC SYRINGES WITH PARTS OF THE SHELF CARTONS FROM LOT # 9231073 AND LOT # 9322390. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD. ALL RETURNED SYRINGES WERE EXAMINED AND ALL WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9322390. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200861364] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231073. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200843441] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200842833] NOTED FOR RAISED HUBS. THERE WAS ONE (1) NOTIFICATION [200833554] NOTED FOR OUT OF SPEC SHIELD PULL. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, 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. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES FROM LOTS 9231073 AND 9322390 HAD ISSUES WITH NEEDLE HUB SEPARATION BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RELION CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD 3 SYRINGES AFFECTED BUT ONLY HAS "DATE OF EVENT" FOR 1 OUT OF THE 3".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9231073, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2019-10-17, MEDICAL DEVICE LOT #: 9322390, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-01-20. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES FROM LOTS 9231073 AND 9322390 HAD ISSUES WITH NEEDLE HUB SEPARATION BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RELION CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD 3 SYRINGES AFFECTED BUT ONLY HAS "DATE OF EVENT" FOR 1 OUT OF THE 3".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217699 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 SEE SECTION H.10. 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1