BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK TIP SYRINGE

    MDR report key: 11930253 · Received June 3, 2021

    Report

    Report Number
    3003152976-2021-00311
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: ONE PHOTO ALONG WITH MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE PLUNGER RODS ARE OBSERVED TO BE BENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2004050, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE MATERIALS USED TO MANUFACTURE THE PLUNGERS ALLOWS FOR A FLEXIBLE MATERIAL THAT MAY BEND WHEN EXPOSED TO WEIGHT. THE PLUNGERS ARE STORED IN HOPPERS UNTIL ASSEMBLY AND IF FILLED WITH EXCESS WEIGHT, THE PLUNGER MAY BEND OR BECOME DEFORMED AS SEEN IN THE SAMPLES RETURNED. ADDITIONALLY, THIS SAME DEFECT CAN OCCUR WHEN BULK PRODUCT IS STORED IN A BAG THAT IS SEALED TOO TIGHTLY. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. RECORDS WERE REVIEWED FOR LOT 2004050 AND NO ISSUES WERE IDENTIFIED. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, WE CAN CONFIRM THE ROOT CAUSE IF RELATED TO THE PRODUCT BEING STORED WITH EXCESSIVE WEIGHT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 98 BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGES HAD BENT, DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ENTIRE SYRINGE WAS BENT. ESPECIALLY THE PISTON OF THE SYRINGE IS VERY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825831 BD PLASTIPAK LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2004050

    Patients

    Seq Age Sex Outcome Treatment
    1