BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK

    MDR report key: 8317438 · Received February 7, 2019

    Report

    Report Number
    2243072-2019-00183
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 8, 2019
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: D.4 MEDICAL DEVICE CATALOG #: MBC6010, D.1. MEDICAL DEVICE BRAND NAME: BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK, D.2. COMMON DEVICE NAME: BLOOD COLLECTION SET, D. 1 MEDICAL DEVICE TYPE: FMI, G.5. PMA / 510(K)#: K172763.

    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 A BLOOD COLLECTION DEVICE W/MALE LUER HAD BREAK OFF IN THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BLOOD COLLECTION DEVICE W/MALE LUER HAD BREAK OFF IN THE NEEDLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLOOD COLLECTION DEVICE W/MALE LUER HAD BREAK OFF IN THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111969 BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BLOOD COLLECTION SET FMI BECTON DICKINSON 18052501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other