BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CAT PLUS BLOOD COLLECTION TUBES

    MDR report key: 8453282 · Received March 26, 2019

    Report

    Report Number
    9617032-2019-00343
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 9, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS OBSERVED. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES AND PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. 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 · 0

    IT WAS REPORTED THAT BD VACUTAINER® CAT PLUS BLOOD COLLECTION TUBES HAD FOREIGN MATTER ON THE TUBES. THIS OCCURRED ON 26 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "A CUSTOMER HAS JUST RAISED OUR ATTENTION TO A BATCH OF 367895 (26 UNITS) WHICH HAVE HAD WATER LIKE BLOTCHES ON THE TUBES (PLEASE SEE ATTACHED IMAGE). PLEASE CAN YOU CONFIRM WHAT THIS COULD BE AS IT IS INSIDE THE PLASTIC AND NO OPENED, WE HAVE 26 OF THESE IN STOCK AND ARE QUESTIONING IF THESE ARE FAULTY/CONTAMINATED AND ARE NO LONGER SAFE FOR OUR CUSTOMERS. PLEASE ADVISE? BOUGHT UNDER THE PO:161859".

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® CAT PLUS BLOOD COLLECTION TUBES HAD FOREIGN MATTER ON THE TUBES. THIS OCCURRED ON 26 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "A CUSTOMER HAS JUST RAISED OUR ATTENTION TO A BATCH OF 367895 (26 UNITS) WHICH HAVE HAD WATER LIKE BLOTCHES ON THE TUBES (PLEASE SEE ATTACHED IMAGE). PLEASE CAN YOU CONFIRM WHAT THIS COULD BE AS IT IS INSIDE THE PLASTIC AND NO OPENED, WE HAVE 26 OF THESE IN STOCK AND ARE QUESTIONING IF THESE ARE FAULTY/CONTAMINATED AND ARE NO LONGER SAFE FOR OUR CUSTOMERS. PLEASE ADVISE? BOUGHT UNDER THE PO: (B)(6)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247174 BD VACUTAINER® CAT PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8176616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other