BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 23G ETW X 7MM PEN NEEDLE¿ US

    MDR report key: 8476308 · Received April 2, 2019

    Report

    Report Number
    1920898-2019-00312
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 25, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382904736989
    PMA / PMN Number
    N/A
    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: CUSTOMER RETURNED (1) 7MM, 23G PEN NEEDLE FROM LOT # 7152649. CUSTOMER STATES THAT THE WHITE PART OF THE SEALING WAS PEELED AND THE CLEAR PART REMAINED. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED DELAMINATION OF THE TEAR DROP LABEL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# (B)(4). ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. AS PER ATTACHED INVESTIGATION REPORTED COMPLETED BY MANUFACTURING, "PROBABLE ROOT CAUSE FOR THE DELAMINATION OF THE TEAR DROP LABEL IS FROM FOREIGN MATERIAL ON TOP OF THE SPRING PACK CAUSING MORE FORCE TO BE APPLIED DURING APPLICATION OR FROM A WORN PIVOT ARM BEING TOO LOOSE ON THE SPRING PACK DURING APPLICATION. CAPA #(B)(4) WAS OPENED (B)(6) 2017 TO ADDRESS DELAMINATION ISSUES ON THE PEN NEEDLE LINE. THE CAPA WAS DETERMINED EFFECTIVE ON (B)(6) 2018."

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A SEALING DEFECT WITH A BD 23G ETW X 7MM PEN NEEDLE¿ US. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT FOUND SEALING DEFECT WHEN HE/SHE OPENED THE PACKAGE. TO BE SPECIFIC, THE WHITE PART OF THE SEALING WAS PEELED AND THE CLEAR PART REMAINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER PHONE #: 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 THERE WAS A SEALING DEFECT WITH A BD 23G ETW X 7MM PEN NEEDLE¿ US. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT FOUND SEALING DEFECT WHEN HE/SHE OPENED THE PACKAGE. TO BE SPECIFIC, THE WHITE PART OF THE SEALING WAS PEELED AND THE CLEAR PART REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269740 BD 23G ETW X 7MM PEN NEEDLE¿ US PEN NEEDLE FMI BD MEDICAL - DIABETES CARE 7152649 00382904736989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other