BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SPC TRCE GH 13X100 7.0 PLBLCE D/BL

    MDR report key: 12129860 · Received July 7, 2021

    Report

    Report Number
    9617032-2021-00731
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #:1012147. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2021-01-12. MEDICAL DEVICE LOT #: 1012151. MEDICAL DEVICE EXPIRATION DATE: 01/31/2022. DEVICE MANUFACTURE DATE: 2021-01-12. INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES, 1 FOR LOT 1012147 AND 2 FOR LOT 1012151, FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR TUE BREAKAGE WITH THE INCIDENT LOT WAS OBSERVED. BD WAS NOT ABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR WHY THE TUBES BROKE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE TUBE SPC TRCE GH 13X100 7.0 PLBLCE D/BL, THE DEVICE EXPERIENCED CRACKED TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TEAM WAS FILLING TUBES WHEN SEVERAL TUBES BROKE ON THE FILLING INSTRUMENT. THE BROKEN TUBES WERE ISOLATED AND THE CANNULA WAS FOUND TO HAVE PIERCED THROUGH THE SIDE OF THE SLEEVE, RESULTING IN A SKEWED SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026144 TUBE SPC TRCE GH 13X100 7.0 PLBLCE D/BL BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1012147

    Patients

    Seq Age Sex Outcome Treatment
    1