BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10347208 · Received July 30, 2020

    Report

    Report Number
    1920898-2020-00964
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 9, 2020
    Report Date
    August 26, 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: 2020-08-24. H.6. INVESTIGATION SUMMARY . CUSTOMER RETURNED (1) 1/2CC, 12.7MM, 29G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9133588. CUSTOMER STATES THAT THE SCALE MARKING ON THE BARREL WAS FAINT AND ILLEGIBLE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED MISSING SCALE MARKINGS FROM THE 40-50 UNIT MARKINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9133588. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200825097, 200825243] NOTED FOR MISSING ZERO LINES. THERE WAS ONE (1) NOTIFICATION [200824982] NOTED FOR MISSING PRINT. THERE WAS ONE (1) NOTIFICATION [200825098] NOTED FOR SCRATCHED PRINT. THERE WERE THREE (3) NOTIFICATIONS [200824594, 200824466, 200824414] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE: QUALITY NOTIFICATION #200825098 WAS OPENED FOR SCRATCHED SCALE LINE. A BARREL WAS STUCK IN THE INFEED DIAL. CORRECTIVE ACTION: THE BARREL WAS REMOVED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: D.4. MEDICAL DEVICE LOT #: 9133588. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10 RETURNED TO MANUFACTURER ON: 2020-08-12. H.3. DEVICE RETURN TO MANUF?: YES. H.4. DEVICE MANUFACTURE DATE: 2019-05-13.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SCALE MARKING ON THE BARREL WAS FAINT AND ILLEGIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SCALE MARKING ON THE BARREL WAS FAINT AND ILLEGIBLE.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SCALE MARKING ON THE BARREL WAS FAINT AND ILLEGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812640 SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9133588

    Patients

    Seq Age Sex Outcome Treatment
    1 Other