BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 14BAG 700CAS JP

    MDR report key: 10604094 · Received September 29, 2020

    Report

    Report Number
    9616656-2020-00976
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 10, 2020
    Report Date
    September 14, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0112333, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-21, MEDICAL DEVICE LOT #: 0112334, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-21. (B)(4). INVESTIGATION SUMMARY: A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, INCORRECT/MISSING LABEL INFORMATION) WAS CAPTURED AND ADDRESSED. 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 THE PEN NDL 31 GA 8 MM 14 BAG 700CAS JP EXPERIENCED INCORRECT LABEL INFORMATION. IT HAS NOT BEEN SPECIFIED WHETHER THE PRODUCT DEFECT WAS NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A BARCODE ISSUE FOR 320102. THE VENDOR REPORTS THAT THE BARCODE ON THE SHELF CARTON COULD NOT BE READ. BDJ CHECKED THIS ISSUE AND NOTICED THAT THE PRODUCT ID CODE HAD BEEN CHANGED FROM (B)(4) TO (B)(4) IN MARCH 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068306 PEN NDL 31GA 8MM 14BAG 700CAS JP PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other