BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 12533655 · Received September 27, 2021

    Report

    Report Number
    2243072-2021-02392
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    August 30, 2021
    Report Date
    September 1, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS THAT COULD APPLY AS MANUFACTURER IS UNKNOWN THE INFORMATION FOR BOTH 510K IS AS FOLLOWS: PMA / 510(K)#: K151766 ((B)(4)), K1107771 ((B)(4)). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP, THE DEVICE EXPERIENCED THE NEEDLE BEING CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED:   IT WAS REPORTED THAT CALLER REPORTED PLUNGER IS STUCK. CALLER REPORTED PLUNGER IS STUCK. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. DID ISSUE CAUSE ANY INJURY? NO. RESOLUTION: CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER TANDEM FOLLOW UP IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434778 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON 309657 UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1