BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA

    MDR report key: 10330212 · Received July 27, 2020

    Report

    Report Number
    1920898-2020-00937
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    June 12, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED AS OF 11 SEPTEMBER 2020 THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. TWO (2) PHOTOS OF 31GX6MM, 1ML BD INSULIN SYRINGE SAMPLES WERE PROVIDED. CUSTOMER REPORTED IT TEND TO HURT SINCE THE SIZE OF THE NEEDLE IS UNUSUAL AND LARGE; IT IS MENTIONED AS 6MM NEEDLE BUT IT IS SEEMINGLY ABOUT 10MM,WHICH ACTUALLY HURTS AND TEND TO PULL THE BLOOD OUT. THE PROVIDED PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT TWO SYRINGES WERE CAPTURED, HOWEVER, NO EVIDENCE OF MANUFACTURING DEFECT COULD BE DETERMINED FROM THE PHOTOS ALONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231170. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA NEEDLE WAS "ABOUT 10 MM" LONG AND HURT THE CONSUMER DURING THE INJECTION. THE DEFECT WAS FOUND WITH 10 DIFFERENT NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USING THE SYRINGE FOR NEARLY 20 YEARS AND I WAS HAPPY WITH THE PRODUCT. BUT RECENTLY WHEN I PURCHASED THE BD GLIDE WITH TBL 6MM NEEDLE, IT TENDS TO HURT SINCE THE SIZE OF THE NEEDLE IS UNUSUAL AND LARGE. IT IS MENTIONED AS 6MM NEEDLE BUT IT IS SEEMINGLY ABOUT 10MM, WHICH ACTUALLY HURTS AND TEND TO PULL THE BLOOD OUT. I CHECKED IT ONCE IN ALL OTHER MEDICALS/PHARMACY, IT SEEMS TO BE OF 10MM NEEDLE ONLY.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA NEEDLE WAS "ABOUT 10 MM" LONG AND HURT THE CONSUMER DURING THE INJECTION. THE DEFECT WAS FOUND WITH 10 DIFFERENT NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USING THE SYRINGE FOR NEARLY 20 YEARS AND I WAS HAPPY WITH THE PRODUCT. BUT RECENTLY WHEN I PURCHASED THE BD GLIDE WITH TBL 6MM NEEDLE, IT TENDS TO HURT SINCE THE SIZE OF THE NEEDLE IS UNUSUAL AND LARGE. IT IS MENTIONED AS 6MM NEEDLE BUT IT IS SEEMINGLY ABOUT 10MM, WHICH ACTUALLY HURTS AND TEND TO PULL THE BLOOD OUT. I CHECKED IT ONCE IN ALL OTHER MEDICALS/PHARMACY, IT SEEMS TO BE OF 10MM NEEDLE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789128 SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other