BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 8392626 · Received March 5, 2019

    Report

    Report Number
    1917413-2019-00368
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 15, 2019
    Report Date
    April 18, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 LEAKAGE FROM MOLDING DEFECT WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE INSPECTED FROM BD INVENTORY FOR EVALUATION OF MOLD B30 CAVITY 42 NONE WERE FOUND. TUBES FROM MOLD B30 CAVITY 42 WERE MOLDED AND FOUND NO MOLDING DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR FINISHED PRODUCT AND TUBE WERE 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#893122 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR LEAKAGE FROM MOLDING DEFECT WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION OF THE CUSTOMER SAMPLES WAS CONDUCTED, AND LEAKAGE FROM MOLDING DEFECT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE RETAIN SAMPLES AND NEWLY MOLDED PRODUCT WAS CONDUCTED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA#893122 AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: CAPA#893122 WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. 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. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD VACUTAINERS® EDTA 2K EXPERIENCED BLOOD LEAKAGE FROM THE GATE OF THE TUBE WITH THE CUSTOMER REPORTING, "BLOOD LEAKED FROM THE GATE OF THE TUBE.¿

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO CUSTOMER SAMPLES WERE RETURNED FROM THE CUSTOMER FOR EVALUATION. 10 PHOTOS WERE RETURNED. THE PHOTOS DO SHOW THE CUSTOMER¿S FAILURE MODE OF ¿LEAKAGE¿. THE DEVICE HISTORY RECORDS (INCLUDING THE SUB-ASSEMBLY DEVICE HISTORY RECORDS) WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. INVESTIGATION CONCLUSION: THE DEVICE HISTORY RECORDS (INCLUDING THE SUB-ASSEMBLY DEVICE HISTORY RECORDS) WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. UPON EVALUATION OF THE CUSTOMER RETURNED PHOTOS, THE CUSTOMER¿S PRODUCT ISSUE WAS OBSERVED DURING VISUAL INSPECTION OF THE PHOTOS. THE 100 PRODUCTION LOT IN-HOUSE RETENTION SAMPLES WERE INSPECTED FOR MOLD B30, CAVITY 42 WITH NO TUBES BEING IDENTIFIED. 5,000 PARTS FROM MOLD B30 WERE INSPECTED THAT WERE MOLDED ON 1/31/19 AND FOUND NO DOUBLE SHOT INDICATING THAT THE PARTS ARE NOT STICKING IN THE PRESS. REVIEWING THE CUSHION ALARM HISTORY FOR THE PRESS, THERE ARE VERY FEW OR NO ALARMS PRIOR TO OR IN THE MONTHS AND WEEKS FOLLOWING THE MANUFACTURED TIME FRAME TO CURRENT DAY, SO IT APPEARS TO BE AN ISOLATED EVENT. THE DEVICE HISTORY RECORDS (INCLUDING THE SUB-ASSEMBLY DEVICE HISTORY RECORDS) WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE ROOT CAUSE FROM EVALUATION OF THE PHOTOS APPEARS TO BE A DOUBLE SHOT, WHERE MATERIAL WAS STICKING IN THE MOLD. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED. RATIONALE: BD PAS RECEIVED NO SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. 10 PHOTOS WERE RECEIVED FROM THE CUSTOMER FACILITY FOR EVALUATION. THE CUSTOMER¿S FAILURE MODE OF ¿LEAKING¿ WAS IDENTIFIED IN THE PHOTOS. THE DEVICE HISTORY RECORDS (INCLUDING THE SUB-ASSEMBLY DEVICE HISTORY RECORDS) WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO BD VACUTAINERS® EDTA 2K EXPERIENCED BLOOD LEAKAGE FROM THE GATE OF THE TUBE WITH THE CUSTOMER REPORTING, "BLOOD LEAKED FROM THE GATE OF THE TUBE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186005 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8249516

    Patients

    Seq Age Sex Outcome Treatment
    0 Other
    1 Other| O