BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 32G 4MM HP 100 BOX FR

    MDR report key: 10320765 · Received July 24, 2020

    Report

    Report Number
    9616656-2020-00727
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. (B)(4). INVESTIGATION SUMMARY: A REVIEW OF RISK MANAGEMENT DOCUMENT 10000084266, REVISION 10, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (NANO PRO PEN NEEDLE, NEEDLE BENT NPE, NEEDLE BENT PE, DIFFICULT/UNABLE TO OPERATE & GLUCOSE LEVEL) WAS CAPTURED AND ADDRESSED APPROPRIATELY. NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. INVESTIGATION CONCLUSION: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE DESCRIPTION: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX FR WERE INVOLVED WITH HYPERGLYCEMIA DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INDEED FOR SEVERAL WEEKS YOUR NEEDLES HAVE BEEN FOLDED, OVER OR EVEN INSIDE WHEN YOU REMOVE THE PAPER OR WHEN YOU TAKE OFF THE SMALL CAP. FORTUNATELY I PURGE EVERY TIME OTHERWISE THERE WOULD BE DAMAGE. HOWEVER, LAST THURSDAY THE INJECTION DID NOT WORK CORRECTLY, MY BLOOD SUGAR LEVEL WAS AROUND 4.80.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788240 PEN NDL 32G 4MM HP 100 BOX FR PEN NEEDLE FMI BECTON DICKINSON AND CO. 9275395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other