BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 11091246 · Received December 29, 2020

    Report

    Report Number
    3003916417-2020-00373
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 3, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, 200 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP OFF AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD IS REVIEWING SPECIFIC AREAS IN THE MANUFACTURING PROCESS RELATING TO THIS ISSUE. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER PULLED OUT OF A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR DURING TRANSPORT. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL TUBES ARE OPENING VERY EASILY IN TRANSPORT, NORMAL HANDLING AFTER COLLECTION AND IN CENTRIFUGES. THIS PROBLEM IS GENERATING A HIGH NUMBER OF RECOLLECTIONS PER BUMPY SAMPLE. CUSTOMER INFO: BATCH NUMBER IS 0111083. THERE WAS A LOSS OF THE SAMPLE, GENERATING MANY COLLECTIONS AND DELAYS IN THE RESULTS. THERE WERE NOT EXPOSURE, THE SAMPLES THAT WERE TRANSPORTED WERE INSIDE PLASTIC BAGS AND THE TUBES THAT WERE UNCAPPED IN THE CENTRIFUGES DID NOT CAUSE DAMAGE TO ANY EMPLOYEE. IT IS USED BD HOLDER IN THE COLLECT. RARELY THEY DO OPEN COLLECT, THEY ALWAYS PRIORITIZE VACUUM COLLECTION. CENTRIFUGATION: 10 MIN 3500 RPM - THE CENTRIFUGE IS BALANCED AND IT IS USED PROPERLY BUCKETS. THE SAMPLE WAS LOST DUE TO THE STOPPER POP OFF AND THE TUBES DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER EMAIL: (B)(6). INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER PULLED OUT OF A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR DURING TRANSPORT. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL TUBES ARE OPENING VERY EASILY IN TRANSPORT, NORMAL HANDLING AFTER COLLECTION AND IN CENTRIFUGES. THIS PROBLEM IS GENERATING A HIGH NUMBER OF RECOLLECTIONS PER BUMPY SAMPLE. CUSTOMER INFO: BATCH NUMBER IS 0111083. THERE WAS A LOSS OF THE SAMPLE, GENERATING MANY COLLECTIONS AND DELAYS IN THE RESULTS. THERE WERE NOT EXPOSURE, THE SAMPLES THAT WERE TRANSPORTED WERE INSIDE PLASTIC BAGS AND THE TUBES THAT WERE UNCAPPED IN THE CENTRIFUGES DID NOT CAUSE DAMAGE TO ANY EMPLOYEE. IT IS USED BD HOLDER IN THE COLLECT. RARELY THEY DO OPEN COLLECT, THEY ALWAYS PRIORITIZE VACUUM COLLECTION. CENTRIFUGATION: 10 MIN 3500 RPM - THE CENTRIFUGE IS BALANCED AND IT IS USED PROPERLY BUCKETS. THE SAMPLE WAS LOST DUE TO THE STOPPER POP OFF AND THE TUBES DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554768 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 0111083

    Patients

    Seq Age Sex Outcome Treatment
    1