BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X3/8 IB

    MDR report key: 11616749 · Received April 5, 2021

    Report

    Report Number
    1911916-2021-00288
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    February 15, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305110 AND LOT NUMBER 9212458. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR WHILE PASSING THE NEEDLE THROUGH THE STOPPER VIAL CLOGGING THE NEEDLE WITH THE STOPPER VIAL MATERIAL. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS SUCH AS A VISION SYSTEM THAT INSPECTS 100% OF ALL PRODUCTS FOR CLOGGED NEEDLES. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. IT COULD BE POSSIBLE THAT WHILE PASSING THE NEEDLE THROUGH THE STOPPER VIAL/ CARTRIDGE THE NEEDLE GOT CLOGGED WITH THE STOPPER MATERIAL. DURING THE MANUFACTURING PROCESS A VISION SYSTEM IS INSPECTING 100% ALL THE PRODUCTS FOR CLOGGED NEEDLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE 26X3/8 IB EXPERIENCED NEEDLE AND SYRINGE SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305110, BATCH NO. 9212458. CALLER REPORTED FILL RESISTANCE ISSUE. NUMBER OF OCCURRENCES: 1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE?: YES. DOES INSULIN COME OUT OF THE EXISTING NEEDLE? - NO, INSTRUCTED CALLER TO CHANGE THE NEEDLE. WAS CALLER ABLE TO FILL THE EXISTING CARTRIDGE WITH THE SECOND NEEDLE?: YES. DISTRIBUTOR TO SEND GOODWILL ORDER OF CARTRIDGES TO REPLACE NEEDLE. IS PRODUCT AVAILABLE FOR RETURN TO BD?: NO. RESOLUTION: CALLER SUCCESSFULLY LOADED CARTRIDGE WITH INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512037 NEEDLE 26X3/8 IB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9212458

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR