BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX FR

    MDR report key: 12051485 · Received June 23, 2021

    Report

    Report Number
    9616656-2021-00717
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 9121511, 9176410, 9317877, 9204977, 0049364, AND 9169569. THESE DO NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SIX OPEN SAMPLES FROM LOT. NO. 9121511, VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON FIVE SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING ONE SAMPLE. FOUR OPEN SAMPLES FROM LOT. NO. 9176410, VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING TWO SAMPLES. TWO OPEN SAMPLES FROM LOT. NO. 9317877, VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE AND BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE SECOND SAMPLE. ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE FROM LOT. NO. 0049364, VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND BROKEN NON PATIENT END OF CANNULA WAS OBSERVED. FIVE OPEN SAMPLES FROM LOT. NO. 9169569, VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THREE SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING THREE SAMPLES. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP 100 BOX FR NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946015 PEN NDL 32G 4MM HP 100 BOX FR PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1