BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8588370 · Received May 7, 2019

    Report

    Report Number
    2243072-2019-00874
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH ON APRIL OF 2019, IMPORTER REPORT # (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. WITHOUT A LOT# IT COULD BE CANAAN OR CUAUTITLAN. (B)(4). PMA / 510(K)#: K980987 OR K151766. 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. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCALES MARKING ERROR OCCURRED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "MATERIAL NO: 309657 BATCH NO: UNKNOWN. IT WAS REPORTED THAT MULTIPLE SYRINGES WERE MISSING THE MARKING'S FOR DOSING ON THEM. PER MEDWATCH REPORT: EMERGENCY CENTER STAFF NOTICED AND REPORTED THAT MULTIPLE 3ML SYRINGES DID NOT HAVE MARKINGS ON THEM FOR DOSING. THE EFFECTED PRODUCT WAS REMOVED FROM SERVICE BEFORE REACHING ANY PATIENTS, HOWEVER, LOT INFORMATION WAS NOT RECORDED PRIOR TO REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378307 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other