BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 8701638 · Received June 14, 2019

    Report

    Report Number
    1024879-2019-01002
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR EXCESSIVE GLUE/FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT 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 PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR EXCESSIVE GLUE/FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THERE WAS FOREIGN MATTER A YELLOW GLUE TYPE SUBSTANCE AT THE BASE OF NEEDLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: A NURSE REPORTS TO US THIS DAY A POTENTIAL DEFECT ON A BLUE VACUTAINER ADAPTER REF 367300, LOT 8214977 PER 31-07-2021. IT HAS YELLOW "GLUE" AT THE BASE OF THE NEEDLE. SO I OPENED AN ADAPTER THAT I HAD IN STOCK OF ANOTHER LOT (LOT 8073627, PER 31-03-2021) WHICH PRESENTS THE SAME THING IN LESS PRONOUNCED IS IT A MANUFACTURING DEFECT? CAN THE ADAPTER BE USED WITHOUT CONSEQUENCES FOR THE PATIENT AND / OR THE SAMPLE?

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THERE WAS FOREIGN MATTER A YELLOW GLUE TYPE SUBSTANCE AT THE BASE OF NEEDLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: A NURSE REPORTS TO US THIS DAY A POTENTIAL DEFECT ON A BLUE VACUTAINER ADAPTER REF: 367300, LOT :8214977, PER: 31-07-2021. IT HAS YELLOW "GLUE" AT THE BASE OF THE NEEDLE. SO I OPENED AN ADAPTER THAT I HAD IN STOCK OF ANOTHER LOT (LOT: 8073627, PER: 31-03-2021) WHICH PRESENTS THE SAME THING IN LESS PRONOUNCED IS IT A MANUFACTURING DEFECT? CAN THE ADAPTER BE USED WITHOUT CONSEQUENCES FOR THE PATIENT AND / OR THE SAMPLE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494771 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8214977

    Patients

    Seq Age Sex Outcome Treatment
    1 Other