BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L CONNECTOR C90J

    MDR report key: 9810434 · Received March 10, 2020

    Report

    Report Number
    3003152976-2020-00108
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 9, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE PHOTO SHOWING A UNIT PACKAGE FROM MATERIAL NUMBER 515113, LOT CODE 1902103 WAS PROVIDED. HOWEVER, NO EVIDENCE WAS PROVIDED TO VERIFY THE PRODUCT WAS MIXED IN A SHELF CARTON OF ITEM 515309 LOT CODE 1902105. A DEVICE HISTORY REVIEW FOR BOTH LOTS 1902103 AND1902105 DID NOT REVEAL ANY ANNOTATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS RELATED TO THIS ISSUE. BOTH LOT 1902103 AND 1902105 WERE MANUFACTURED AND SENT FOR STERILIZATION DURING SEPARATE MONTHS, NEVER BEING HOUSED WITHIN THE FACILITY DURING THE SAME TIME. PRODUCT UNDERGOES VISUAL INSPECTIONS PRIOR TO RELEASE, INCLUDING VERIFYING THE PROPER PRODUCT AND QUANTITY IS WITHIN EACH PACKAGE. ALL INSPECTIONS FOR THESE LOTS WERE COMPLETED ACCORDING TO PROCEDURE, NO ANNOTATIONS WERE NOTED RELATED TO THE REPORTED INCIDENT. ONCE THIS PROCESS IS COMPLETE, THE PRODUCT WAS SENT TO BD JAPAN AND INSPECTIONS OF ALL UNITS ARE PERFORMED. INSPECTION RECORDS WERE REVIEWED, AND IT WAS VERIFIED THAT THE INSPECTIONS FOR THESE PRODUCTS WERE PERFORMED AT THE SAME TIME. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT IS LIKELY RELATED TO THE INSPECTOR PLACING THE INCORRECT ITEM NUMBER WITHIN THE SHELF CARTON FOR ITEM 515309. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO ENSURE ALL MATERIAL NUMBERS ARE PROPERLY VERIFIED BEFORE PLACING IN THE SHELF CARTON. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE L CONNECTOR C90J EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PRODUCT OF CAT#5151113(LOT:1902103) GOT MIXED IN THE SHELF CARTON OF CAT#515309(LOT:1902105). PROBABLE LOT# OF CAT#515309 IS 1902105.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE L CONNECTOR C90J EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PRODUCT OF CAT#5151113 (LOT: 1902103) GOT MIXED IN THE SHELF CARTON OF CAT#515309 (LOT: 1902105). PROBABLE LOT# OF CAT#515309 IS 1902105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278247 L CONNECTOR C90J BD PHASEAL CONNECTOR LHI BECTON DICKINSON, S.A. 1902105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other