BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 10112495 · Received June 2, 2020

    Report

    Report Number
    9610847-2020-00166
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9213231. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ONE USED PHYSICAL SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLE, IT WAS DETERMINED THAT THE LEAKAGE RESULTED FROM A DEFECT IN THE VALVE PORT. THIS DEFECT MOST LIKELY RESULTED FROM AN ERROR IN THE ASSEMBLY PROCESS. IN RESPONSE TO THIS INCIDENT, A NOTIFICATION WAS ISSUED TO CHANGE THE SEQUENCE OF LEAKAGE TESTING DURING THE MANUFACTURING PROCESS IN ORDER TO DETECT THIS POTENTIAL SOURCE OF LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A GASTRECTOMY IT WAS NOTED THAT THE PILLOW WAS DAMP WHEN THE DR WENT TO INJECT A DRUG. THE WHITE CLIP ON CAP WAS NOT ENGAGED ACROSS THE INJECTION PORT AND FLUID COULD BE VISIBLE SEEN OOZING OUT ¿ THERE WAS NO PRESSURE BAG ON THE IV FLUIDS AND A FILTER NEEDLE HAD BEEN USED TO DRAW UP THE IV DRUGS. HARTMANNS SOLN WAS RUNNING THROUGH THE LINE. CONNECTA DISCONNECTED AND HELD FOR INSPECTION. A NEW CONNECTA OPENED AND USED TO COMPLETE THE TREATMENT WITH NO ISSUES.

    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 CONNECTA¿ STOPCOCK EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A GASTRECTOMY IT WAS NOTED THAT THE PILLOW WAS DAMP WHEN THE DR WENT TO INJECT A DRUG. THE WHITE CLIP ON CAP WAS NOT ENGAGED ACROSS THE INJECTION PORT AND FLUID COULD BE VISIBLE SEEN OOZING OUT ¿ THERE WAS NO PRESSURE BAG ON THE IV FLUIDS AND A FILTER NEEDLE HAD BEEN USED TO DRAW UP THE IV DRUGS. HARTMANNS SOLN WAS RUNNING THROUGH THE LINE. CONNECTA DISCONNECTED AND HELD FOR INSPECTION. A NEW CONNECTA OPENED AND USED TO COMPLETE THE TREATMENT WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571559 BD CONNECTA STOPCOCK STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9213231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other