BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 8956425 · Received September 3, 2019

    Report

    Report Number
    1911916-2019-00897
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 14, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: FOUR (4) SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLES WERE VISUALLY EXAMINED, TWO (2) OF THE RETURNED SAMPLES HAD MINOR SCALE PRINTING ISSUED BUT NO SCRATCHES WERE OBSERVED IN THE BARRELS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION CONCLUSION THE CONDITION REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL NO.: 302832 BATCH NO.: 9182467, 9149628, 9120516 IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ TIP SYRINGE THERE ARE SCRATCHES ON THE BARREL. THERE ARE SCRATCHES ON THE BARREL OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9182467. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-07-01. MEDICAL DEVICE LOT #: 9149628. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-29. MEDICAL DEVICE LOT #: 9120516. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-30. 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

    MATERIAL NO.: 302832 BATCH NO.: 9182467, 9149628, 9120516. IT WAS REPORTED THAT DURING USE OF THE BD LUER-LOK¿ TIP SYRINGE THERE ARE SCRATCHES ON THE BARREL. THERE ARE SCRATCHES ON THE BARREL OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750640 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other