BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 10646462 · Received October 7, 2020

    Report

    Report Number
    1920898-2020-01378
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 6, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 DIMENSION, NEEDLE BLUNT AND NEEDLE PAIN ON LOT # 9091596. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, DIMENSION, NEEDLE BLUNT AND NEEDLE PAIN) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 1CC SYRINGES. CUSTOMER STATES THAT THE NEEDLE IS THICKER THAN NORMAL, CAUSING PAIN WHEN APPLYING MEDICATIONS AND THEY HAVE RESISTANCE ENTERING THE SKIN AND THE TIPS ARE NOT SHARP CAUSING PAIN. THE PHOTOS WERE EXAMINED AND IT IS DIFFICULT TO DETERMINE IF THE SAMPLES FALL WITHIN SPECIFICATIONS REGARDING THE CANNULA DIMENSIONS THAT COULD POTENTIALLY CAUSE PAIN. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9091596. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE 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. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE WAS DAMAGED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINS THAT THE BD ULTRA FINE SYRINGE INSULIN 6MM 100U ULTRA-FINE NEEDLE IS THICKER THAN NORMAL, CAUSING PAIN WHEN APPLYING MEDICATIONS. IT HAS BEEN HAPPENING FOR ABOUT 2 MONTHS. THEY HAVE RESISTANCE TO PENETRATE THE SKIN. APPARENTLY THE SYRINGES PURCHASED IN THIS PACKAGE HAVE THEIR TIPS NOT "SHARP" CAUSING PAIN WHEN USING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104997 BD ULTRA-FINE INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 9091596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other