BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 1/2IN

    MDR report key: 18409961 · Received December 28, 2023

    Report

    Report Number
    3002682307-2023-00364
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    November 24, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220610. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES OF REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. TWENTY MICROLANCE3 NEEDLES G30 OF OUR RETAINED SAMPLES FROM THE REPORTED LOT, WERE ASSEMBLED WITH A CAVERJECT SYRINGE PROVIDED BY THE COSTUMER IN THE PAST. WE ASSEMBLED THE NEEDLE WITH THE SYRINGE FOLLOWING THE INSTRUCTIONS OF THE CAVERJET KIT WHICH ARE THE REGULAR PRACTICES. POSITIONING THE HUB IN THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. ANY OF THE SYRINGES EXAMINED PRESENTED THE REPORTED DEFECT; THE HUB FITS PROPERLY WITH THE SYRINGE TIP AND NO LEAKAGE IS OBSERVED. SINCE WE WERE UNABLE TO DUPLICATE OR REPRODUCE YOUR INDICATED FAILURE MODE BECAUSE OUR RETAINED SAMPLES SHOWED NO DEFECT, AND REVIEW OF DHR SHOW NO ABNORMALITIES DURING NEEDLES MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED NEEDLE MANUFACTURING PROCESS IS NOT POSSIBLE TO DETERMINE, AT THIS TIME. TAKING INTO ACCOUNT AVAILABLE INFORMATION ¿PRODUCT LEAKAGE; AS A RESULT, THE PATIENT WAS UNABLE TO INJECT THE FULL DOSE.'¿ WE UNDERSTAND A DEFECTIVE HUB CONNECTION ISSUE COULD HAVE TAKEN PLACE. BASED ON OUR EXPERIENCE, THIS ISSUE COULD BE PROBABLY BECAUSE OF A DEFECTIVE CONNECTIVITY DUE TO A DEFECTIVE LUER DIMENSIONS OR ANY DAMAGE IN THE SYRINGE TIP, BUT IT COULD BE ALSO RELATED WITH THE HANDLING OF THE PRODUCT AS SOME INSUFFICIENT ADJUSTMENT BETWEEN OF THE DEVICES BY THE END USER. ON THE OTHER HAND, WE ARE CERTAIN THAT THE PROBABILITY OF HAVING SOME DAMAGED NEEDLE CAUSING DETACHED IN OUR PRODUCT IS VERY LOW BASED ON THE PREVENTIVE MEASURES, AND OUR SAMPLING INSPECTION PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 30GA 1/2IN LEAKED AT THE CONNECTION BETWEEN THE CANULA AND THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE WOULD LIKE TO INFORM YOU THAT WE HAVE RECEIVED A CUSTOMER COMPLAINT REGARDING A NEEDLE QUALITY PROBLEM ("LEAKAGE AT THE CONNECTION OF THE CANULA TO THE SYRINGE"). ADDITIONAL INFORMATION RECEIVED ON 06-DEC-2023. HAS THERE BEEN AN IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE IN TREATMENT NEEDED)? PRODUCT LEAKAGE; AS A RESULT, THE PATIENT WAS UNABLE TO INJECT THE FULL DOSE. ADDITIONAL INFORMATION RECEIVED ON 07-DEC-2023. RECONSTITUTED SOLUTION CAVERJECT. PRODUCT LEAKAGE - THEREFORE INCOMPLETE DOSE INJECTION.

    Description of Event or Problem · 0

    (B)(6) 2023. IT IS STATED THAT THE PATIENT WAS NOT ABLE TO COMPLETE THEIR DOSE OF MEDICATION DUE TO THE LEAKAGE. WAS THERE AN ADVERSE AFFECT TO THE PATIENT'S HEALTH BECAUSE THEY RECEIVED AN INCOMPLETE DOSE? IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE AN ALTERNATIVE TREATMENT DO TO THIS EVENT? RESPONSE FROM CUSTOMER ON (B)(6) 2024. NOT TO OUR KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269504 BD NEEDLE 30GA 1/2IN NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 220610 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown