BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8736309 · Received June 26, 2019

    Report

    Report Number
    9614033-2019-00174
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO PHYSICAL SAMPLE OR CUSTOMER PHOTOGRAPH IS RECEIVED TO EVALUATE THE REPORTED FOREIGN MATTER. 10 PIECES OF RETENTION SAMPLES ARE SENT TO THE QUALITY CONTROL LABORATORY FOR A VISUAL AND FUNCTIONAL EVALUATION IN ORDER TO VERIFY THE DEFECT THAT THE CLIENT REPORTS. THE RETENTION SAMPLES PRESENTED SATISFACTORY RESULTS, NO DEFECTS FOUND. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    MATERIAL NO: 309657 BATCH NO: 8222920. IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SEVERAL SYRINGES WOULD NOT CONNECT PROPERLY WITH THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT HE WENT THROUGH SEVERAL SYRINGES AND NEEDLES BECAUSE THE TWO COULD CONNECT PROPERLY; AS A RESULT, HE COULD NOT FILL THE CARTRIDGE PROPERLY.

    Additional Manufacturer Narrative · 1

    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

    MATERIAL NO: 309657, BATCH NO: 8222920. IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SEVERAL SYRINGES WOULD NOT CONNECT PROPERLY WITH THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT HE WENT THROUGH SEVERAL SYRINGES AND NEEDLES BECAUSE THE TWO COULD CONNECT PROPERLY; AS A RESULT, HE COULD NOT FILL THE CARTRIDGE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531446 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222920 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 43 MO Other