BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER,TUBING

    MDR report key: 7411182 · Received April 10, 2018

    Report

    Report Number
    1024879-2018-00118
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 16, 2018
    Report Date
    May 1, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8008616; MEDICAL DEVICE EXPIRATION DATE: 12/31/2019; DEVICE MANUFACTURE DATE: 02/01/2018. MEDICAL DEVICE LOT #: 8008616; MEDICAL DEVICE EXPIRATION DATE: 12/31/2019; DEVICE MANUFACTURE DATE: 02/01/2018. MEDICAL DEVICE LOT #: 8003523; MEDICAL DEVICE EXPIRATION DATE: 12/31/2019 ; DEVICE MANUFACTURE DATE: 02/01/2018. MEDICAL DEVICE LOT #: 8003523; MEDICAL DEVICE EXPIRATION DATE: 12/31/2019; DEVICE MANUFACTURE DATE: 02/01/2018. MEDICAL DEVICE LOT #: 8008616. MEDICAL DEVICE EXPIRATION DATE: 12/31/2019. DEVICE MANUFACTURE DATE: 02/01/2018. MEDICAL DEVICE LOT #: 8003523. MEDICAL DEVICE EXPIRATION DATE: 12/31/2019. DEVICE MANUFACTURE DATE: 02/01/2018. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SEPARATION OF THE TUBING FROM THE IV NEEDLE/SAFETY SHIELD ASSEMBLY WITH THE INCIDENT LOT WAS OBSERVED; HOWEVER, THE PHOTO DID NOT IDENTIFY ANY ISSUES WITH THE HOLDER SEPARATING. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND NO ISSUE RELATING TO THE TUBING OR HOLDER SEPARATING WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BOTH INCIDENT LOTS AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SEPARATION OF THE TUBING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS CONDUCTED AND NO ISSUES RELATING TO SEPARATION OF THE TUBING OR HOLDER WAS OBSERVED. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOLDER OF BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, TUBING SEPARATES DURING COLLECTION, AND THE TUBING SEPARATES FROM SAFETY SHIELD. FOUND DURING USE. THE USER DID NOT REPORT SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254077 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER,TUBING BLOOD COLLECTION SET/ TUBES JKA BECTON, DICKINSON & CO., (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other