BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8549665 · Received April 25, 2019

    Report

    Report Number
    1911916-2019-00410
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 10, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIXTEEN (16) SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION IN UNOPENED BLISTER PACKS. FOUR (4) OF THE SAMPLES WERE SELECTED AT RANDOM AND WERE LEAK TESTED BY A QUALITY CONTROL REPRESENTATIVE. NONE OF THE FOUR SAMPLES LEAKED WHEN TESTED. LEAKAGE CAN BE CAUSED BY THE INTERACTION BETWEEN THE BARREL INSIDE DIAMETER, THE STOPPER OUTSIDE DIAMETER, AND PLUNGER ROD BAYONET OUTSIDE DIAMETER AND FORCES APPLIED DURING USE. THE SYRINGE IS MORE LIKELY TO LEAK WHEN FORCES ARE APPLIED TO THE PLUNGER ROD WHEN FULLY EXTENDED. A CORRECTIVE ACTION PREVENTIVE ACTION, (B)(4) HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WAS DAMAGED AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED PROBLEM IN TWO BATCHES OF 60 ML SYRINGES, MANUFACTURER BD. THEY HAVE THE PLUNGER DAMAGED, CAUSING LEAKS. I NEED TO NOTIFY URGENTLY, BECAUSE IT IS MATERIAL USED IN THE PREPARATION OF CHEMOTHERAPY DRUGS. LEAK HAPPENS BETWEEN THE PLUNGER AND THE WALL OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8240871; MEDICAL DEVICE EXPIRATION DATE: 2023-08-31; DEVICE MANUFACTURE DATE: 2018-08-28; MEDICAL DEVICE LOT #: 8130616; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2018-05-10. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WAS DAMAGED AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED PROBLEM IN TWO BATCHES OF 60 ML SYRINGES, MANUFACTURER BD. THEY HAVE THE PLUNGER DAMAGED, CAUSING LEAKS. I NEED TO NOTIFY URGENTLY, BECAUSE IT IS MATERIAL USED IN THE PREPARATION OF CHEMOTHERAPY DRUGS. LEAK HAPPENS BETWEEN THE PLUNGER AND THE WALL OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343563 BD LUER-LOK SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other