BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE LUER-LOK TIP

    MDR report key: 9666975 · Received February 4, 2020

    Report

    Report Number
    1213809-2020-00049
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 15, 2020
    Report Date
    March 16, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS AND ONE LOOSE 5ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 8161744 (P/N 309649) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE THUMB REST WAS ALMOST COMPLETED BROKEN OFF, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8161744 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLUNGER ERROR OCCURRED BEFORE USE WITH A BD 5ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING USE OF THE SYRINGE, THE TIP OF THE PLUNGER PARTIALLY DETACHED FROM THE PLUNGER RENDERING THE SYRINGE UNUSABLE."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PLUNGER ERROR OCCURRED BEFORE USE WITH A BD 5ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING USE OF THE SYRINGE, THE TIP OF THE PLUNGER PARTIALLY DETACHED FROM THE PLUNGER RENDERING THE SYRINGE UNUSABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132093 BD 5ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 8161744 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other