BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10106998 · Received June 1, 2020

    Report

    Report Number
    1920898-2020-00600
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 24, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/19/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (3) 3/10CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 9231320. CUSTOMER STATES THAT A SHIELD WAS TIGHT AND WHEN IT WAS REMOVED BY FORCE, THE HUB DETACHED. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DEFECTS WERE OBSERVED ON THE REMAINING SAMPLES. 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. 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. CAPA#1630423 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB DETACHED FROM THE SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP WHEN THE "TIGHT" SHIELD WAS REMOVED BEFORE USE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "A SHIELD WAS TIGHT. WHEN REMOVED IT WITH FORCE, THE HUB WAS DETACHED TOO."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE HUB DETACHED FROM THE SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP WHEN THE "TIGHT" SHIELD WAS REMOVED BEFORE USE. THIS OCCURRED ON 3 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A SHIELD WAS TIGHT. WHEN REMOVED IT WITH FORCE, THE HUB WAS DETACHED TOO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567980 SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9231320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other