BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA

    MDR report key: 10485042 · Received September 2, 2020

    Report

    Report Number
    1920898-2020-01156
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 13, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    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 16 OCTOBER 2020 THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THREE (3) PHOTOS REGARDING THE REPORTED ISSUE WITH 1ML BD INSULIN SYRINGES FROM LOT 9231170 WERE PROVIDED. CONSUMER REPORTED THERE IS A WOUND AT INSULIN INJECTION SITE, WHICH DEVELOPED BECAUSE OF HARDNESS OF INSULIN INJECTION PLUNGER, AND NOW THE WOUND IS HEALING SLOWLY. ALL 3 PROVIDED PHOTOS WERE REVIEWED, AND NO EVIDENCE OF A DEFECT COULD NOT BE DETERMINED FROM THE PHOTOS ALONE. SINCE NO ISSUES WERE OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231170. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200842457] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200841002] NOTED FOR OUT OF SPEC BREAKOUT AND SUSTAINING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA PLUNGER WAS DIFFICULT TO MOVE. THIS OCCURRED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A WOUND AT INSULIN INJECTION SITE, WHICH DEVELOPED BECAUSE OF HARDNESS OF INSULIN INJECTION PLUNGER. AND NOW THE WOUND IS HEALING SLOWLY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA PLUNGER WAS DIFFICULT TO MOVE. THIS OCCURRED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A WOUND AT INSULIN INJECTION SITE, WHICH DEVELOPED BECAUSE OF HARDNESS OF INSULIN INJECTION PLUNGER. AND NOW THE WOUND IS HEALING SLOWLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950457 SYRINGE 1.0ML 31GA 6MM U40 10BAG INDIA SYRINGE FMF BD MEDICAL - DIABETES CARE 9231170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other