BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PEDS PLUS/ F CULTURE VIALS

    MDR report key: 12169864 · Received July 14, 2021

    Report

    Report Number
    1119779-2021-01171
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 20, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K954927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BOTTLE INSIDE THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS BROKE AND BLOOD LEAKAGE OCCURRED. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BROKEN BOTTLE THAT WAS LEAKING IN THEIR INSTRUMENT MEDICAL DEVICE BRAND NAME: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS. MEDICAL DEVICE CATALOG #: 442194. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. UNIQUE IDENTIFIER (UDI) #: (B)(4). MEDICAL DEVICE SERIAL #: NA. PMA / 510(K)#: K954927. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE NEITHER BATCH NUMBER NOR RETURNED GOODS SAMPLES WERE AVAILABLE. BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR PRODUCT RELEASE. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. COMPLAINT WAS NOT CONFIRMED. LETTER # SHQ ¿ 170 SHOULD BE PROVIDED TO CUSTOMER. 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 THE BOTTLE INSIDE THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS BROKE AND BLOOD LEAKAGE OCCURRED. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BROKEN BOTTLE THAT WAS LEAKING IN THEIR INSTRUMENT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOTTLE INSIDE THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS BROKE AND BLOOD LEAKAGE OCCURRED. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BROKEN BOTTLE THAT WAS LEAKING IN THEIR INSTRUMENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 BOTTLE INSIDE THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED BROKE AND BLOOD LEAKAGE OCCURRED. THERE WAS NO REPORT OF USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BROKEN BOTTLE THAT WAS LEAKING IN THEIR INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064530 BD BACTEC PEDS PLUS/ F CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 UNKNOWN 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1