BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 0.3ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 10102809 · Received May 29, 2020

    Report

    Report Number
    1920898-2020-00585
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 3/10CC SYRINGES. CUSTOMER STATES THAT WHEN REMOVING A SHIELD, NEEDLE HUB WAS DETACHED TOO. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231320. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CONCLUSION: 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 ROOT CAUSE:A VISUAL EVALUATION OF PHOTO FOUND (2) SYRINGES WITH NO NEEDLE ASSEMBLY ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE WAS NO HUB INSIDE OF THE SHIELD. 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 #77156 WAS CREATED FOR RAISED HUBS. THE PRESS STATION WAS OUT OF ADJUSTMENT. CORRECTIVE ACTION: THE PRESS STATION WAS ADJUSTED. RATIONALE: TIP-2019-37 WAS IMPLEMENTED ON (B)(6) 2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE OF HUB SEPARATES.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE SYR 0.3ML 30GA 8MM 7BAG 420CAS JP HAD THE HUB SEPARATE FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED WHEN "REMOVING THE SHIELD, THE NEEDLE HUB ALSO DETACHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567427 SYR 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9231320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other