BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN

    MDR report key: 9766349 · Received February 27, 2020

    Report

    Report Number
    1920898-2020-00184
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 23, 2020
    Report Date
    February 24, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER IN SYRINGE ON LOT # 9042986. INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTOS OF A LOOSE 1CC U40 INSULIN SYRINGE. CUSTOMER STATES THAT THERE IS FOREIGN MATTER IN THE INSULIN SYRINGE DURING USAGE. THE PHOTO WAS EXAMINED AND EXHIBITED A DARK PIECE OF MATERIAL IN THE BARREL OF THE SYRINGE. IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM A PHOTO. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042986. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS 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 IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE PHOTO. 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 2 SYRINGE 1.0ML 29GA 1/2IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSULIN SYRINGE WAS SOLD WITH INSULIN INJECTION. MEDICAL PERSONNEL NOTICED FOREIGN MATTER IN THE INSULIN SYRINGE DURING USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230795 SYRINGE 1.0ML 29GA 1/2IN SYRINGE FMF BD MEDICAL - DIABETES CARE 9042986

    Patients

    Seq Age Sex Outcome Treatment
    1 Other