BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 15327694 · Received August 31, 2022

    Report

    Report Number
    2243072-2022-01436
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 17, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NIPRO. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET INCREASE IN THE REPORTING OF HAEMOLYSED SAMPLES. THIS HAS OCCURRED 1320 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE MONTH OF JULY NUH HAVE SEEN AN INCREASE IN THE REPORTING OF HAEMOLYSED SAMPLES .THE FIGURES ARE ACROSS THE CAMPUS AND INCLUDE A SMALL AMOUNT OF GP SAMPLES. DUE TO THE SUPPLY DISRUPTION NUH HAVE TAKEN RECEIPT OF MORE BLUE GAUGE SETS. THE FIGURES ARE BELOW;8-14TH JUL ¿ 389 HAEMOLYSED K15-21ST JUL ¿ 428 HAEMOLYSED K22-29TH JUL ¿ 503 HAEMOLYSED KI HAVE ATTACHED A CONVERSATION USING A WORD DOCUMENT BETWEEN THE LABS AND A NURSE ON AMRA [ACUTE MEDICINE RECEIVING AREA] WARD .I AM NOT STATING THAT THERE IS A FAULT WITH THE PROSUM SET, THIS IS THE CODE WE HAVE BEEN USING PRIMARILY ON ESCALATION. WE HAVE RECEIVED 5,750 EACH'S. I CAN ALSO SEE FROM THE JULY TR REPORT THAT WE HAVE RECEIVED 18,950 BD BLUE GAUGE AND ONLY 500 GREEN GAUGE SETS [ BD]THIS IS AFFECTING PATIENT FLOW AND CAPACITY DUE TO SECOND SAMPLES BEING REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067715 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown