BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INSULIN 0.5ML 31GA 8MM W30 SELF

    MDR report key: 10469469 · Received August 29, 2020

    Report

    Report Number
    9614033-2020-00118
    Event Type
    Malfunction
    Date Received
    August 29, 2020
    Date of Event
    August 12, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION: COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT TO OPERATE (CANNOT INSERT NEEDLE), NEEDLE BENT, NEEDLE LOOSE AND NEEDLE PAIN ON LOT # 0013095. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, DIFFICULT TO OPERATE, NEEDLE BENT, NEEDLE LOOSE AND NEEDLE PAIN) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A LOOSE 1/2CC, 8MM, 31G SYRINGE WITH THE SHELF CARTON FROM LOT # 0013095. CUSTOMER STATES THAT THE NEEDLE CANNOT BE INSERTED TO REMOVE THE INSULIN FROM THE VIAL; BECAUSE THEY ARE CROOKED AND LOOSE, IT DOES NOT HAVE THE STRENGTH TO PASS THE PROTECTOR OF THE VIAL TO EXTRACT THE INSULIN AND IT HURT TO GIVE THE INJECTION. THE PHOTOS WERE EXAMINED AND NO BENT SYRINGE WAS OBSERVED. IT IS DIFFICULT TO DETERMINE IF THE SYRINGE SHOWN IN THE PHOTOS IS ABLE TO FUNCTION PROPERLY, IF THE SYRINGE IS LOOSE, OR IF THERE IS PAIN SOLELY FROM THE ATTACHED PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013095. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THIS COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE INSULIN 0.5ML 31GA 8MM W30 SELF WAS UNABLE TO DRAW INSULIN. THIS OCCURRED ON 8 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE CANNOT BE INSERTED TO REMOVE THE INSULIN FROM THE VIAL; BECAUSE THEY ARE CROOKED AND LOOSE, IT DOES NOT HAVE THE STRENGTH TO PASS THE PROTECTOR OF THE VIAL TO EXTRACT THE INSULIN. ADDITIONAL INFORMATION: IT WAS INJECTED WITH SUCH A NEEDLE AND IT HURT TO GIVE THE INJECTION. IT WAS PAINFUL TO USE IT LIKE THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934059 SYRINGE INSULIN 0.5ML 31GA 8MM W30 SELF SYRINGE FMF BECTON DICKINSON DE MEXICO 0013095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other