BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ SUPPLEMENT VX WITH RECONSTITUTING FLUID

    MDR report key: 20025146 · Received August 22, 2024

    Report

    Report Number
    1119779-2024-00617
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    June 21, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    PPM
    UDI-DI
    00382902335412
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - SUPPLEMENT VX KIT BATCH 4128488 IS COMPOSED OF SUPPLEMENT VX BATCH 4096937 AND SUPPLEMENT VX RECONSTITUTION FLUID BATCH 3191124. THE BATCH HISTORY RECORD REVIEW FOR SUPPLEMENT VX KIT BATCH 4128488 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. THE COMPLAINT HISTORY WAS REVIEWED AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS KIT BATCH. SUPPLEMENT VX ENRICHMENT IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). SUPPLEMENT VX RECONSTITUTION FLUID IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENOUS SOLUTION IS OBTAINED. THE SOLUTION IS STERILE FILTERED, DISPENSED INTO VIALS AND CAPPED AND CRIMPED PER SOP. COMPONENT VIALS ARE LABELED AND PACKAGED IN A SEPARATE PACKING AREA. SIX SUPPLEMENT VX ENRICHMENT VIALS ARE THEN MANUALLY PACKAGED WITH SIX SUPPLEMENT VX RECONSTITUTION FLUID VIALS TO MAKE A SUPPLEMENT VX SUPPLEMENT KIT (MATERIAL 233541). THE BATCH HISTORY RECORD REVIEWS FOR SUPPLEMENT VX BATCH 4096937 AND SUPPLEMENT VX RECONSTITUTION FLUID BATCH 3191124 WERE SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE LABELING PROCESS FOR MATERIAL 233541 INCLUDES LABEL RECONCILIATION WHERE THE TOTAL NUMBER OF LABELS ISSUED IS RECONCILED WITH THE TOTAL QUANTITY OF LABELS USED ON (CARTONS/BOTTLES/TUBES/ETC.), USED IN THE BATCH HISTORY RECORD, REJECTED AND UNUSED. ANY DISCREPANCIES MUST BE WITHIN ALLOWABLE LIMITS SPECIFIED IN THE LABELING CONTROL PROCEDURE. THE LABEL RECONCILIATION FOR BATCH 4128488 SHOWS THERE WAS NO SHORTAGE OR EXCESS OF LABELS AFTER MANUFACTURING. NO OTHER COMPLAINTS HAVE BEEN TAKEN ON EITHER BATCH. RETENTION SAMPLES WERE AVAILABLE FOR INSPECTION. THERE WERE NO DEFECTS OBSERVED IN THE RETENTION SAMPLES. FIVE PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. ONE PHOTO SHOWED CARTON LABEL 4128488. ONE PHOTO SHOWED SUPPLEMENT 4096937 WITH LYOPHILIZED PRODUCT STUCK TO OUTSIDE OF VIAL. ONE PHOTO SHOWED KIT CARTONS JUMBLED IN THE SHIPPING CONTAINER WITH VIALS STREWN IN THE OUTER BOX AND OUTSIDE OF THE BOX. ONE PHOTO SHOWED RECONSTITUTION FLUID WITH NO LABEL. ONE PHOTO SHOWED A SUPPLEMENT WITH THE VIAL LID BENT UPWARD. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CAN BE CONFIRMED FOR LEAKING, DAMAGED CARTON, MISSING LABEL, AND BROKEN CRIMP CAP FROM THE PHOTOS. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR THESE DEFECTS. BD SHIPS PRODUCT IN TEMPERATURE-CONTROLLED TRUCKS TO DISTRIBUTION CENTERS. DISTRIBUTION CENTERS ARE PROVIDED WITH SHIPPING AND STORAGE GUIDELINES. MISHANDLING OF THE PRODUCT AND VIBRATIONS DURING SHIPPING CAN CAUSE DAMAGED PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD DIFCO¿ SUPPLEMENT VX WITH RECONSTITUTING FLUID, ONE (1) BOTTLE WAS MISSING A PRODUCT LABEL, FOUR (4) BOTTLES LEAKED POWDER, ONE (1) BOTTLE HAD A BENT LID, AND THE CONTENTS OF THE PACKAGE WERE NOT SECURED IN PLACE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD DIFCO¿ SUPPLEMENT VX WITH RECONSTITUTING FLUID, ONE (1) BOTTLE WAS MISSING A PRODUCT LABEL, FOUR (4) BOTTLES LEAKED POWDER, ONE (1) BOTTLE HAD A BENT LID, AND THE CONTENTS OF THE PACKAGE WERE NOT SECURED IN PLACE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397530 BD DIFCO¿ SUPPLEMENT VX WITH RECONSTITUTING FLUID GENERAL PURPOSE REAGENT PPM BECTON DICKINSON & CO. (SPARKS) 4128488 00382902335412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown