BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PEN NEEDLE STERILE SINGLE USE

    MDR report key: 7411174 · Received April 10, 2018

    Report

    Report Number
    1920898-2018-00211
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    February 14, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K110105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 7MM, 23G PEN NEEDLE FROM LOT # 5111782. CUSTOMER STATES THAT THE LABEL WAS NOT ATTACHED TO THE NEEDLE COVER. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED AN INCOMPLETE SEAL BETWEEN THE TEAR DROP LABEL AND THE OUTER COVER OF THE PEN NEEDLE. MANUFACTURING (HOLDREGE) WAS NOTIFIED OF THIS ISSUE. SECOND INVESTIGATION SUMMARY: FROM THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER, IT APPEARS AS THOUGH THE TEAR DROP LABEL SEAL WAS COMPLETED DURING PRODUCTION. FOR A PORTION OF THE SEAL, IT IS UNABLE TO BE DETERMINED FROM THE PHOTO IF A SEAL WAS SUCCESSFUL AND LATER FAILED. AS NO DAMAGE WAS NOTED FROM THE PHOTOGRAPHS TO THE COVER ITSELF, PREVIOUSLY ATTRIBUTABLE ROOT CAUSE SOURCES ASSOCIATED WITH DAMAGE TO THE LABEL CAN NOT BE CORRELATED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 5111782 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR ANY RELATED DEFECTS DURING THE PRODUCTION OF THIS BATCH. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 5111782. BASED ON THE SAMPLES / 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.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR STATED AN INCORRECT "DATE RECEIVED BY MANUFACTURER". THE CORRECT DATE IS 03/21/2018.

    Additional Manufacturer Narrative · 1

    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 A STERILE BD¿ SINGLE USE PEN NEEDLE HAD A DEFECTIVE NEEDLE COVER POSSIBLY CAUSING A STERILE BREACH. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253718 BD¿ PEN NEEDLE STERILE SINGLE USE PEN NEEDLE FMI BD MEDICAL - DIABETES CARE 5111782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other