BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP

    MDR report key: 11730157 · Received April 27, 2021

    Report

    Report Number
    1920898-2021-00468
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING DEFECTIVE ON LOT # 0132186. INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0132186. CUSTOMER STATES THAT THE PRINTING OF SYRINGE SCALE MARK WAS SOMETHING WRONG. ALL RETURNED SYRINGES WERE TESTING USING THE PLUG GAUGE AND ALL SCALE MARKING PLACEMENTS FELL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0132186 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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 ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE PATIENT STATED THAT THERE WAS A LIQUID CONDENSATION AT THE TIP OF THE NEEDLE AND THE PRINTING OF SYRINGE SCALE MARK WAS SOMETHING WRONG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631532 SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0132186

    Patients

    Seq Age Sex Outcome Treatment
    1