BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G ETW X 7MM PEN NEEDLE EU

    MDR report key: 8071015 · Received November 14, 2018

    Report

    Report Number
    1920898-2018-00896
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 26, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7195604. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. A PHOTO WAS RECEIVED FOR EVALUATION. THE SAMPLE IN THE PHOTO APPEARED TO HAVE THE TEAR DROP LABEL PUSHED IN. THE PHOTO PROVIDED BY THE CUSTOMER APPEARS TO EXHIBIT DAMAGE TO THE TEAR DROP LABEL SIMILAR TO PRIOR INVESTIGATIONS WHEREBY THE LABEL WAS PUSHED IN DURING TRANSIT. ALTHOUGH THE DAMAGE TO THIS LABEL IS NOT AS SEVERE AS HAS BEEN NOTED PREVIOUSLY, THE POSITION OF THE TEAR (ALONG THE INNER RIM OF THE COVER) SUGGESTS THAT THE FAILURE MODE IS SIMILAR. (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS THIS, AS WELL AS OTHER FAILURE MODES RESULTING IN AN IMPACT TO THE STERILITY OF THE PRODUCT. VISUAL INSPECTION AND LEAK TEST ARE PERFORMED AT REGULAR INTERVALS DURING PRODUCTION OF A BATCH. AT THE START OF THE SHIFT AND EVERY TWO (2) HOURS THE FOLLOWING SAMPLES QUANTITIES FOR THE LEAK TEST AND VISUAL INSPECTIONS OCCUR: LEAK TEST ¿ LABEL OR COVER 177 PARTS/TEST VISUAL INSPECTION 21 PARTS/TEST IF WITHIN COMPLETION OF ANY INSPECTIONS AND/OR CHALLENGES, ANY OF THE ABOVE NOTED DEFECTS WERE FOUND, THE PRODUCTION LINE WOULD STOP AND ADDRESS THE DEFECT TYPE AND DETERMINE ROOT CAUSE PRIOR TO RESUMING THE PRODUCTION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 23G ETW X 7MM PEN NEEDLE EU HAD A DAMAGED TEARDROP. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 23G ETW X 7MM PEN NEEDLE EU HAD A DAMAGED TEARDROP. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911240 23G ETW X 7MM PEN NEEDLE EU PEN NEEDLE FMI BD MEDICAL - DIABETES CARE 7195604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other