BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK

    MDR report key: 8086159 · Received November 19, 2018

    Report

    Report Number
    2243072-2018-01649
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 17, 2018
    Report Date
    March 29, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K172763
    Removal / Correction Number
    PAS-19-1355-FA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR MULTIPLE LOTS OF THE BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BASED ON CONFIRMED COMPLAINTS OF A BREAKAGE IN THE LUER.  THIS ISSUE COULD CAUSE THE DEVICE TO LEAK OR BREAK OFF AND GET STUCK IN THE FISTULA NEEDLE PORT RENDERING THE PORT INACCESSIBLE FOR DIALYSIS. AS A RESULT, THE PATIENT WOULD NEED TO BE RE-CANNULATED WITH A NEW FISTULA NEEDLE TO OBTAIN THEIR DIALYSIS TREATMENT. PLEASE REFERENCE BD RECALL #: PAS-19-1355-FA, ASSOCIATED WITH RES82317.

    Additional Manufacturer Narrative · 0

    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 THE HUB BREAKING DURING USAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE 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 HUB BREAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORTED MATERIAL # [MBC6010]. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK WAS BREAKING DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION. MEDICAL DEVICE BRAND NAME: BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK. COMMON DEVICE NAME: BLOOD COLLECTION SET. MEDICAL DEVICE TYPE: FMI. PMA / 510(K)#: K172763.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER WAS BREAKING OFF DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER WAS BREAKING OFF DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK WAS BREAKING DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS KDL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER WAS BREAKING OFF DURING USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923000 BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BLOOD COLLECTION SET FMI BECTON DICKINSON 17111501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other