BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 8544500 · Received April 24, 2019

    Report

    Report Number
    1920898-2019-00377
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 7, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1ML, 31G X 8MM BD INSULIN SYRINGE (USED). CONSUMER REPORTED THAT THE SCALE PRINT ON SEVERAL SYRINGES IS INCORRECT; THE TOP LINE OF SOME THE SYRINGES IS MISMARKED SO IT IS DIFFICULT TO GAUGE ONE UNIT. THE RETURNED SAMPLE WAS EXAMINED AND THE TOP LINE OF THE SCALE MARKING WAS OBSERVED TO BE MISSING, THUS CONFIRMING THE ALLEGED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8218538. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200774615] NOTED FOR MISSING SCALE LINE. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING SCALE LINE). CAPA #162566 TO ADDRESS PRINTED BARREL DEFECTS. POSSIBLE ROOT CAUSES FOR MISSING SCALE LINE INCLUDE: DAMAGE TO THE PAD PRINT DRUM NOT TOUCHING THE PAD FOR INK TRANSFER PAD HEAT SET INCORRECTLY PRINT HEAD TIMING OUT OF ADJUSTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328418, BATCH NO. 8218538. VERBATIM: CONSUMER REPORTED THAT THE SCALE PRINT ON SEVERAL SYRINGES IS INCORRECT, OCCURRENCE DATE IS 04-07-19. LOT # 8218538, PRODUCT # 328418, EXP 08-31-2023.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328418, BATCH NO. 8218538. VERBATIM: CONSUMER REPORTED THAT THE SCALE PRINT ON SEVERAL SYRINGES IS INCORRECT, OCCURRENCE DATE IS (B)(6) 2019. LOT # 8218538, PRODUCT # 328418, EXP 08-31-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336687 SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8218538 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other