BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8776756 · Received July 10, 2019

    Report

    Report Number
    1024879-2019-01155
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 25, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION RELATING TO LABEL LIFT THROUGH CAPA#1064141. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#1064141. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA#(B)(4) TO IDENTIFY THE POTENTIAL ROOT CAUSE(S). RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES LABELS ARE PEELING OFF. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986 BATCH NO. 9081740 IT WAS REPORTED THE LABELS ARE PEELING OFF. (2 OF 2 COMPLAINTS) OPENED A SECOND COMPLAINT BECAUSE THE CUSTOMER STATED IT KEEPS OCCURRING. NOT SURE WHAT TO DO AT THIS POINT, BUT LABELS ARE NOT ADHERING TO THE TUBES. IT SHOULD NOT BE TEMP STORAGE ISSUE IN THE PSC BECAUSE THE COMPLAINTS ARE FROM ALL OVER NEW ENGLAND. I WILL TRY AND FIND THE LAST INCIDENT #, IT IS CRAZY LATELY THERE HAVE BEEN SO MANY. I BELIEVE A TUBE WAS SENT BUT HAVE NOT HEARD BACK FROM BD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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® SST¿ BLOOD COLLECTION TUBES LABELS ARE PEELING OFF. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9081740. IT WAS REPORTED THE LABELS ARE PEELING OFF. (2 OF 2 COMPLAINTS) OPENED A SECOND COMPLAINT BECAUSE THE CUSTOMER STATED IT KEEPS OCCURRING. NOT SURE WHAT TO DO AT THIS POINT, BUT LABELS ARE NOT ADHERING TO THE TUBES. IT SHOULD NOT BE TEMP STORAGE ISSUE IN THE PSC BECAUSE THE COMPLAINTS ARE FROM ALL OVER NEW ENGLAND. I WILL TRY AND FIND THE LAST INCIDENT #, IT IS CRAZY LATELY THERE HAVE BEEN SO MANY. I BELIEVE A TUBE WAS SENT BUT HAVE NOT HEARD BACK FROM BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572652 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9081740 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other