BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA

    MDR report key: 10446569 · Received August 24, 2020

    Report

    Report Number
    1920898-2020-01111
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 11 SEPTEMBER 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0020548 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA EXPERIENCED SCALE MARKING ISSUES AND DIFFICULT PLUNGER MOVEMENT PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARENT OF YOUNG CHILD STATED, SCALE MARKINGS ARE WRONG AND HE'S CONCERNED ABOUT ADMINISTERING WRONG AMOUNT TO HIS CHILD. STATED, WHEN STOPPER IS PUSHED ALL THE WAY DOWN AND HE PULLS BACK TO DRAW INSULIN, HE'S GETTING 2 UNITS INSTEAD OF 1 UNIT? STATED, HE IS CONCERNED THAT HE MAY NOT BE GIVING HIS CHILD THE CORRECT DOSAGE. LOT: 0020548. CATALOG: 324919. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA EXPERIENCED SCALE MARKING ISSUES AND DIFFICULT PLUNGER MOVEMENT PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARENT OF YOUNG CHILD STATED, SCALE MARKINGS ARE WRONG AND HE'S CONCERNED ABOUT ADMINISTERING WRONG AMOUNT TO HIS CHILD. STATED, WHEN STOPPER IS PUSHED ALL THE WAY DOWN AND HE PULLS BACK TO DRAW INSULIN, HE'S GETTING 2 UNITS INSTEAD OF 1 UNIT? STATED, HE IS CONCERNED THAT HE MAY NOT BE GIVING HIS CHILD THE CORRECT DOSAGE. LOT: 0020548. CATALOG: 324919. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911054 SYRINGE 0.3ML 31G 6MM HALF UNIT 10BAG CA SYRINGE FMF BD MEDICAL - DIABETES CARE 0020548

    Patients

    Seq Age Sex Outcome Treatment
    1 Other