BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER LOCK

    MDR report key: 8244349 · Received January 14, 2019

    Report

    Report Number
    2243072-2018-01966
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    December 26, 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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 LUER OF THE BD¿ BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BROKE DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION. MEDICAL DEVICE BRAND NAME: BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER LOCK. COMMON DEVICE NAME: BLOOD COLLECTION SET. MEDICAL DEVICE TYPE: FMI. PMA / 510(K)#: K172763.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND MECHANICAL TESTING; UPON COMPLETION, ALL RESULTS MET RELEASE SPECIFICATIONS. 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. BD HAS CONDUCTED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA WHERE IMPROVEMENT OPPORTUNITIES HAVE BEEN IDENTIFIED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE RETAIN SAMPLES, ALL RESULTS MET RELEASE SPECIFICATIONS. HOWEVER, FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA WHERE IMPROVEMENT OPPORTUNITIES HAVE BEEN IDENTIFIED. AS A RESULT, THESE IMPROVEMENTS ARE BEING IMPLEMENTED TO HELP REDUCE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: A CAPA WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED IMPROVEMENT OPPORTUNITIES IN THE MANUFACTURING PROCESS AND AS A RESULT, THESE IMPROVEMENTS ARE BEING IMPLEMENTED TO HELP REDUCE FURTHER OCCURRENCES. 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 IMPROVEMENT OPPORTUNITIES IN THE MANUFACTURING PROCESS AND AS A RESULT, THESE IMPROVEMENTS ARE BEING IMPLEMENTED TO HELP REDUCE FURTHER OCCURRENCES.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER LOCKS EXPERIENCED BREAKAGE AND LEAKED DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUERS EXPERIENCED BREAKAGE AND LEAKED DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUERS EXPERIENCED BREAKAGE AND LEAKED DURING USE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUERS EXPERIENCED BREAKAGE AND LEAKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38054 BD¿ MAXGUARD BLOOD COLLECTION DEVICE WITH MALE LUER LOCK BLOOD COLLECTION SET FMI BECTON DICKINSON 18052501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other