BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17425763 · Received July 31, 2023

    Report

    Report Number
    3008352382-2023-00112
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 21, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5. PMA/510K INFO: K113558, K222591. H.3. 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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3008352382-2023-00112 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE STOPPER WAS DEFECTIVE AND LEAKING OCCURRED FROM A DENTED RUBBER STOPPER. THIS ISSUE OCCURRED WITH 3 BOTTLES AND NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT TYPE OF DEFECTIVE RUBBER STOPPER? LEAKING FROM A DENTED RUBBER STOPPER. WHEN WAS ISSUE DETECTED? PRIOR TO USE OR AFTER USE? FOUND BEFORE USE. THE RUBBER STOPPER WAS DEFECTIVE AND THE CONTENTS OF THE BLOOD BOTTLE LEAKED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE STOPPER WAS DEFECTIVE AND LEAKING OCCURRED FROM A DENTED RUBBER STOPPER. THIS ISSUE OCCURRED WITH 3 BOTTLES AND NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT TYPE OF DEFECTIVE RUBBER STOPPER? -- LEAKING FROM A DENTED RUBBER STOPPER. WHEN WAS ISSUE DETECTED? PRIOR TO USE OR AFTER USE? -- FOUND BEFORE USE. THE RUBBER STOPPER WAS DEFECTIVE AND THE CONTENTS OF THE BLOOD BOTTLE LEAKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653679 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3019563 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown