BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ GELATIN

    MDR report key: 17760918 · Received September 15, 2023

    Report

    Report Number
    1119779-2023-01003
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    July 31, 2023
    Report Date
    November 22, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT RELATED TO BOTTLE GELATIN 500G, CATALOG NUMBER 214340, BATCH 2143804 FOR PRESENCE OF FOREIGN MATERIAL. COMPONENTS ARE MILLED AND BLENDED (WHERE REQUIRED) AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCURS, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. RELEASE TESTING CONSISTS OF DEHYDRATED MEDIUM APPEARANCE, SOLUBILITY, SOLUTION APPEARANCE, AND GROWTH PERFORMANCE WITH ORGANISMS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO OTHER CONFIRMED COMPLAINTS ON THIS PRODUCT FOR THE DEFECT IN QUESTION. ELEVEN PHOTOS WERE RECEIVED IN LIEU OF RETURNS. SEVERAL PHOTOS DEPICT MICROSCOPIC VIEWS OF PARTICLES. ONE PHOTO APPEARS TO BE A SMALL DARK IMPURITY CIRCLED IN RED SUSPENDED IN THE GELATIN. RETENTION SAMPLES FROM THE COMPLAINT LOTS WERE TESTED FOR POWDER AND PREPARED SOLUTION APPEARANCES AGAINST A REFERENCE LOT OF GELATIN. SATISFACTORY POWDER APPEARANCE IS LIGHT BEIGE, FREE FLOWING, AND HOMOGENEOUS. REFERENCE AND RETENTIONS WERE LIGHT BEIGE, FREE FLOWING, AND HOMOGENEOUS. NO IMPURITIES WERE OBSERVED. THE SAMPLES WERE PREPARED AS A 12% SOLUTION. FLASKS WERE PLACED AT 50-55°C IN A WATERBATH TO DISSOLVE THE GELATIN. SOLUTIONS WERE AUTOCLAVED AT 121°C FOR 15 MINUTES AND COOLED IN A WATERBATH AT 45-50°C. SOLUTION APPEARANCE WAS NOTED. SATISFACTORY SOLUTION APPEARANCE IS LIGHT AMBER, CLEAR TO OPALESCENT, MAY HAVE A SLIGHT PRECIPITATE. REFERENCE AND RETENTIONS WERE SATISFACTORY; LIGHT AMBER, OPALESCENT, WITH NO SIGNIFICANT PRECIPITATE. NO DARK IMPURITIES WERE OBSERVED IN THE FLASKS. THE RETENTIONS WERE COMPARABLE TO THE REFERENCE. THE CUSTOMER STATED THAT THE FOREIGN MATERIAL FOUND IN THEIR SAMPLE WAS FURTHER CHARACTERIZED AS PROTEIN AND ORGANIC MATTER, METALLIC PARTICLES, CITRATE, AND FLUOROPOLYMERS. AS THE GELATIN INGREDIENT IN THIS FORMULATION IS DERIVED FROM BIOLOGICAL MATERIALS, ANY MINUTE INSOLUBLE PARTICLES ATTRIBUTED TO THESE SOURCES WOULD BE CONSIDERED INHERENT. BD WAS UNABLE TO REPLICATE THE DARK IMPURITIES OBSERVED BY THE CUSTOMER IN RETENTION SAMPLES. THIS COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD DIFCO¿ GELATIN THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER. BLACK FM WAS FOUND IN THE PACKAGE OF LABEL NUMBER (B)(6) DURING DISSOLUTION. IDENTIFICATION ANALYSIS SUGGESTED THAT IT CONSISTED MAINLY OF PROTEIN (POSSIBLY GELATIN NOT REMOVED) AND CARBON-BASED MATERIALS (ACTIVATED CHARCOAL, CARBONIZED ORGANIC MATTER, SOOT, ETC.). ANOTHER BLACK FM FROM THE SAME PACKAGE WAS IDENTIFIED AS METALLIC POWDER, MAINLY IRON, OR ITS OXIDE. FM WAS ALSO FOUND DURING POWDER WEIGHING. PALE BLUE SMALL LUMPS (FOUND IN PACKAGE (B)(6). IDENTIFICATION ANALYSIS REVEALED THAT IT CONSISTED MAINLY OF CITRATE (PRESUMED TO BE MAINLY SODIUM SALT) AND AGAR, AND WAS PRESUMED TO CONTAIN FLUOROPOLYMER. BLUE-GREEN FM (FOUND IN PACKAGE (B)(6). IDENTIFICATION ANALYSIS INDICATED THAT IT CONSISTED MAINLY OF WATER-SOLUBLE NITROGEN-CONTAINING COMPOUNDS AND AGAR, AND WAS THOUGHT TO CONTAIN PROTEIN AND FLUOROPOLYMER. BLACK FM (FOUND IN PACKAGES (B)(6)). THE RESULTS OF THE IDENTIFICATION ANALYSIS INDICATED THAT IT CONSISTED MAINLY OF PROTEIN AND WAS CONSIDERED TO CONTAIN STAINLESS STEEL METAL FINES OR THEIR OXIDES.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING BD DIFCO¿ GELATIN THAT THERE WAS BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER. BLACK FM WAS FOUND IN THE PACKAGE OF LABEL NUMBER 00006 DURING DISSOLUTION. IDENTIFICATION ANALYSIS SUGGESTED THAT IT CONSISTED MAINLY OF PROTEIN (POSSIBLY GELATIN NOT REMOVED) AND CARBON-BASED MATERIALS (ACTIVATED CHARCOAL, CARBONIZED ORGANIC MATTER, SOOT, ETC.). ANOTHER BLACK FM FROM THE SAME PACKAGE WAS IDENTIFIED AS METALLIC POWDER, MAINLY IRON, OR ITS OXIDE. FM WAS ALSO FOUND DURING POWDER WEIGHING. PALE BLUE SMALL LUMPS (FOUND IN PACKAGE #6000). IDENTIFICATION ANALYSIS REVEALED THAT IT CONSISTED MAINLY OF CITRATE (PRESUMED TO BE MAINLY SODIUM SALT) AND AGAR, AND WAS PRESUMED TO CONTAIN FLUOROPOLYMER. BLUE-GREEN FM (FOUND IN PACKAGE #5000). IDENTIFICATION ANALYSIS INDICATED THAT IT CONSISTED MAINLY OF WATER-SOLUBLE NITROGEN-CONTAINING COMPOUNDS AND AGAR, AND WAS THOUGHT TO CONTAIN PROTEIN AND FLUOROPOLYMER. BLACK FM (FOUND IN PACKAGES #00005, #00006). THE RESULTS OF THE IDENTIFICATION ANALYSIS INDICATED THAT IT CONSISTED MAINLY OF PROTEIN AND WAS CONSIDERED TO CONTAIN STAINLESS STEEL METAL FINES OR THEIR OXIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779071 BD DIFCO¿ GELATIN SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 2143804

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown