BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 9136040 · Received September 30, 2019

    Report

    Report Number
    9614033-2019-00242
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    August 21, 2019
    Report Date
    December 5, 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

    H.6. INVESTIGATION SUMMARY: THREE SAMPLES RECEIVED FOR INVESTIGATION. TEST WERE PERFORMED INCLUDING VOLUMETRIC PRESSURE, VISUAL INSPECTION, AND PLUNGER RELEASE FORCE, THE TEST WERE COMPLIANT NO DEFECT OBSERVED. DURING THE LEAKAGE TEST, TWO OF THE THREE SAMPLES ANALYZED LEAKED DUE TO A DEFORMATION OF THE SYRINGE TIP, HOWEVER IT IN UNSURE WHETHER THE DEFECT WAS PRESENT PRIOR TO SAMPLE MANIPULATION. FURTHERMORE, 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. AFTER THE TESTS PERFORMED, NO PRODUCT DEFECTS WERE FOUND THAT COULD CAUSE PROBLEMS OF RELEASE, IN ADDITION, THE CUSTOMER REPORTED THAT THE DEFECT OCCURRED AT THE TIME OF TRYING TO RELEASE THE INSULIN, SO IT IS POSSIBLE THAT THE NEEDLE USED DURING TREATMENT COULD BE DEFECTIVE. THE DEFECT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, NO CORRECTIVE ACTIONS ARE NECESSARY. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DRAW ISSUE OCCURRED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PLUNGER ON THE SYRINGE WILL NOT RELEASE THE INSULIN ONCE ITS IN." 3 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8222927. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-11-12. MEDICAL DEVICE LOT #: 8222973. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-09-25. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 DRAW ISSUE OCCURRED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PLUNGER ON THE SYRINGE WILL NOT RELEASE THE INSULIN ONCE ITS IN." 3 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931521 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO SEE H.10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other