BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR

    MDR report key: 15448187 · Received September 19, 2022

    Report

    Report Number
    3003916417-2022-00194
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    September 5, 2022
    Report Date
    November 8, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 100 SAMPLES AND 1 VIDEO FOR INVESTIGATION. THE VIDEO WAS EVALUATED AND THE ISSUE OF STOPPER POP OFF WAS OBSERVED. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 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. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER POP OFF BASED ON THE VIDEO EVIDENCE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-10-03. H.6. INVESTIGATION SUMMARY: MAT: 360057. LOT: 2120745. BD RECEIVED 100 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 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. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER POP OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR DURING SAMPLE DRAW FOR HEMOGRAM EXAM USING THE TUBES, THE STOPPER SPONTANEOUSLY POPS OFF. IT CAUSES THE SAMPLE TO SPILL AND A RE-COLLECTION IS NEEDED. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING SAMPLE DRAW FOR HEMOGRAM EXAM USING THE TUBES, THE STOPPER SPONTANEOUSLY POPS OFF. IT CAUSES THE SAMPLE TO SPILL AND A RE-COLLECTION IS NEEDED. THE ISSUE HAPPENS RANDOMLY, IN ONE TRAY IT'S OBSERVED FROM 3 UP TO 6 TUBES WITH THE PROBLEM. 100 TUBES WERE INSPECTED PRIOR USE SEARCHING FOR DEFECT SIGNS, BUT NO DEVIATION WAS IDENTIFIED. THE ISSUE HAPPENS ONLY AFTER THE TUBES ARE FILLED, BOTH IN VACUUM AND OPEN COLLECTIONS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR DURING SAMPLE DRAW FOR HEMOGRAM EXAM USING THE TUBES, THE STOPPER SPONTANEOUSLY POPS OFF. IT CAUSES THE SAMPLE TO SPILL AND A RE-COLLECTION IS NEEDED. THIS EVENT OCCURRED (B)(4) TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING SAMPLE DRAW FOR HEMOGRAM EXAM USING THE TUBES, THE STOPPER SPONTANEOUSLY POPS OFF. IT CAUSES THE SAMPLE TO SPILL AND A RE-COLLECTION IS NEEDED. THE ISSUE HAPPENS RANDOMLY, IN ONE TRAY IT'S OBSERVED FROM(B)(4) TUBES WITH THE PROBLEM. (B)(4) TUBES WERE INSPECTED PRIOR USE SEARCHING FOR DEFECT SIGNS, BUT NO DEVIATION WAS IDENTIFIED. THE ISSUE HAPPENS ONLY AFTER THE TUBES ARE FILLED, BOTH IN VACUUM AND OPEN COLLECTIONS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR DURING SAMPLE DRAW FOR HEMOGRAM EXAM USING THE TUBES, THE STOPPER SPONTANEOUSLY POPS OFF. IT CAUSES THE SAMPLE TO SPILL AND A RE-COLLECTION IS NEEDED. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING SAMPLE DRAW FOR HEMOGRAM EXAM USING THE TUBES, THE STOPPER SPONTANEOUSLY POPS OFF. IT CAUSES THE SAMPLE TO SPILL AND A RE-COLLECTION IS NEEDED. THE ISSUE HAPPENS RANDOMLY, IN ONE TRAY IT'S OBSERVED FROM 3 UP TO 6 TUBES WITH THE PROBLEM. 100 TUBES WERE INSPECTED PRIOR USE SEARCHING FOR DEFECT SIGNS, BUT NO DEVIATION WAS IDENTIFIED. THE ISSUE HAPPENS ONLY AFTER THE TUBES ARE FILLED, BOTH IN VACUUM AND OPEN COLLECTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250201 BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2120745

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown