BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE RNA PLH 16X100 2.5 PLBLCE CLR

    MDR report key: 10015736 · Received April 30, 2020

    Report

    Report Number
    9617032-2020-00382
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 13, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    54053727621653
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE TUBE RNA PLH 16X100 2.5 PLBLCE CLR TUBES (WITHOUT SAMPLE) STORED AT THE WRONG TEMPERATURE AND CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LAB RECEIVED 78 FROZEN PAXGENE BLOOD RNA TUBES FROM ITALY AND 35 OF THEM WERE CRACKED ON THE BOTTOM. THE DAMAGE TUBES WERE NOTICED WHEN THE SAMPLES WERE PULLED FROM THE -80OC FREEZER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE TUBE RNA PLH 16X100 2.5 PLBLCE CLR TUBES (WITHOUT SAMPLE) STORED AT THE WRONG TEMPERATURE AND CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LAB RECEIVED 78 FROZEN PAXGENE BLOOD RNA TUBES FROM (B)(4) AND 35 OF THEM WERE CRACKED ON THE BOTTOM. THE DAMAGE TUBES WERE NOTICED WHEN THE SAMPLES WERE PULLED FROM THE -80OC FREEZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476343 TUBE RNA PLH 16X100 2.5 PLBLCE CLR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 762165 UNKNOWN 54053727621653

    Patients

    Seq Age Sex Outcome Treatment
    1 Other