BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17159809 · Received June 19, 2023

    Report

    Report Number
    2647876-2023-00048
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BD CARIBE, LTD
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K151866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442020. BATCH NO. 2284989 & 2284990. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE 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. 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 ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. CATALOG: 442020. BATCH NO. 2333803. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE 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. 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO TREND IDENTIFIED FOR THIS BATCH. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    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 1 OF 3. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THAT THERE WERE THREE MOLECULAR FALSE POSITIVE RESULTS. ERRONEOUS RESULTS WERE DETERMINED BECAUSE GRAM STAIN RESULTS DID NOT CORRELATE WITH BCID RESULTS. NO ERRONEOUS RESULTS REPORTED TO CLINICIANS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT # 1, 80-CB-23-143146: LOT #: 2284989. SEQUENCE #: (B)(4). INSTRUMENT S/N:(B)(6). NO ERRONEOUS RESULTS REPORTED. BCID RESULT: C. TROPICALIS, STREP SPP., STREP PYOGENES BCID2, LOT #: 2RBT23 GRAM STAIN: GPC IN PAIRS CULTURE GREW STREP PYOGENES"

    Description of Event or Problem · 0

    HOLD KW 6.29 REPORT 1 OF 3 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THAT THERE WERE THREE MOLECULAR FALSE POSITIVE RESULTS. ERRONEOUS RESULTS WERE DETERMINED BECAUSE GRAM STAIN RESULTS DID NOT CORRELATE WITH BCID RESULTS. NO ERRONEOUS RESULTS REPORTED TO CLINICIANS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT # 1, (B)(6): LOT #: 2284989, SEQUENCE #: (B)(4), INSTRUMENT S/N: (B)(6) NO ERRONEOUS RESULTS REPORTED, BCID RESULT: C. TROPICALIS, STREP SPP., STREP PYOGENES, BCID2, LOT #: 2RBT23, GRAM STAIN: GPC IN PAIRS, CULTURE GREW STREP PYOGENES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709526 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BD CARIBE, LTD 442020 2284989 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown