BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK

    MDR report key: 8227838 · Received January 8, 2019

    Report

    Report Number
    2243072-2018-01923
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    December 18, 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. MEDICAL DEVICE BRAND NAME: BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK. MEDICAL DEVICE TYPE: FMI. COMMON DEVICE NAME: BLOOD COLLECTION SET. 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 BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BROKE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR BREAKAGE OF THE LUER HUB WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER SAMPLES, ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT (FROM BD INVENTORY), WERE EVALUATED AND MECHANICALLY TESTED; 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 EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR BREAKAGE OF THE LUER HUB WITH THE INCIDENT LOT WAS OBSERVED. BASED ON EVALUATION/TESTING OF THE CUSTOMER AND 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. 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 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 BD¿ BLOOD COLLECTION TUBE BROKE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ BLOOD COLLECTION TUBE BROKE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22475 BD BLOOD COLLECTION ASSEMBLY WITH MALE LUER LOCK BLOOD COLLECTION SET FMI BECTON DICKINSON 18052501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other