BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

    MDR report key: 20566668 · Received October 30, 2024

    Report

    Report Number
    2647876-2024-00123
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    June 1, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K151866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K173873. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 4151009 D4. MEDICAL DEVICE EXPIRATION DATE: 03-MAR-2025 H4. DEVICE MANUFACTURE DATE: 30-MAY-2024 D.4 UDI#: (B)(6). INVESTIGATION SUMMARY CATALOG 442020 BATCH NO. 4151009 CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. PRE-INCUBATION TO THE RETENTION SAMPLES WAS ALSO PERFORMED FOR VIABLE CONTAMINATION TEST. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND OF THE COMPLAINTS RECEIVED, ONLY ONE COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. THE COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. BD BACTEC¿ MEDIA ARE MANUFACTURED FOLLOWING GOOD MANUFACTURING PRACTICES, WHICH INCLUDE MULTIPLE IN-PROCESS QUALITY CHECKS AND AN AUTOCLAVE MOIST HEAT STERILIZATION PROCESS PREVIOUSLY VALIDATED FOLLOWING ISO 11134 STANDARD. ADDITIONALLY, ALL BD BACTEC¿ MEDIA RELEASED FOR SALE MUST PASS QUALITY CONTROL TESTING BY PROCEDURES CONVENTIONALLY UTILIZED FOR THIS TYPE OF PRODUCT, INCLUDING METHODOLOGY AND CONTROL ATCC CULTURES SPECIFIED IN THE CLSI STANDARD, QUALITY ASSURANCE FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA. CONTROLS ARE ALSO USED DURING EACH PERFORMANCE TESTING. THIS PRODUCT MET BD DIAGNOSTICS - DIAGNOSTIC SYSTEMS STRINGENT QUALITY STANDARDS AT TIME OF BATCH/LOT RELEASE. PRODUCT INSERTS STATES THAT CARE MUST BE TAKEN TO PREVENT CONTAMINATION OF THE SAMPLE DURING COLLECTION AND INOCULATION INTO THE BD BACTEC¿ VIAL. PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSED SEPTUM, OR LEAKAGE. DO NOT USE ANY VIAL SHOWING EVIDENCE OF CONTAMINATION. A CONTAMINATED VIAL COULD CONTAIN POSITIVE PRESSURE. IF A CONTAMINATED VIAL IS USED FOR DIRECT DRAW, GAS OR CONTAMINATED CULTURE MEDIA COULD BE REFLUXED INTO THE PATIENT¿S VEIN. VIAL CONTAMINATION MAY NOT BE READILY APPARENT. PRIOR TO USE, THE USER SHOULD EXAMINE THE VIALS FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS THAT ARE CRACKED OR LEAKING, OR DISPLAY TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. THE SPECIMEN MUST BE COLLECTED USING STERILE TECHNIQUES TO REDUCE THE CHANCE OF CONTAMINATION. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS-FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE. STATE DEPARTMENT IDENTIFIED PARABURKHOLDERIA FUNGORUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN ONE SAMPLE. STATE DEPARTMENT IDENTIFIED PARABURKHOLDERIA FUNGORUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252111 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 4151009 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown