BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® SST¿ TUBES

    MDR report key: 7579913 · Received June 7, 2018

    Report

    Report Number
    2618282-2018-00501
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    November 22, 2017
    Report Date
    May 11, 2018
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6343592; MEDICAL DEVICE EXPIRATION DATE: 02/28/2018; DEVICE MANUFACTURE DATE: 12/08/2016; MEDICAL DEVICE LOT #: 7095632; MEDICAL DEVICE EXPIRATION DATE: 06/30/2018; DEVICE MANUFACTURE DATE: 04/05/2017; MEDICAL DEVICE LOT #: 7163623; MEDICAL DEVICE EXPIRATION DATE: 08/31/2018; DEVICE MANUFACTURE DATE: 06/12/2017; MEDICAL DEVICE LOT #: 7163622; MEDICAL DEVICE EXPIRATION DATE: 08/31/2018; DEVICE MANUFACTURE DATE: 06/12/2017; MEDICAL DEVICE LOT #: 7030930; MEDICAL DEVICE EXPIRATION DATE: 04/30/2018; DEVICE MANUFACTURE DATE: 01/30/2017. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR POOR BARRIER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE CUSTOMER'S INDICATED FAILURE MODE FOR POOR BARRIER WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER AND RETAIN SAMPLES WAS CONDUCTED AND POOR BARRIER WAS NOT OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: A CAPA HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROTAINER® SST¿ TUBES HAD ISSUES WITH POOR BARRIER SEPARATION. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423147 BD MICROTAINER® SST¿ TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 7125982

    Patients

    Seq Age Sex Outcome Treatment
    1 Other