BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 9383638 · Received November 27, 2019

    Report

    Report Number
    9610847-2019-00702
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 12, 2019
    Report Date
    January 23, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: FOUR PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. EACH OF THE RETURNED SAMPLES EXHIBITED A STAINED BLISTER PACKAGE. THE STAIN ON THE PACKAGE WAS ADJACENT TO THE OPENING OF THE RED COMPONENT OF THE PRODUCT. THE PRODUCT WAS EXAMINED AT THIS POINT OF CONTACT AND A THIN FILM LIKE MATERIAL WAS FOUND AT THIS AREA. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS COMPLETED FOR THIS MATERIAL WITH THE RESULTS DETERMINING THAT THE MATERIAL WAS MOST LIKELY SILICONE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE THREE PROVIDED LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS FOR ANY OF THE THREE LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. IT HAS BEEN DETERMINED THAT THIS RESULTED FROM AN EXCESSIVE AMOUNT OF SILICONE BEING DISPERSED FROM THE PRODUCTION STATION WHICH WENT UNDETECTED. BASED ON THE LOW OCCURRENCE OF THIS DEFECT, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA¿ STOPCOCK HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPERATING ROOM OPENED THE PACKAGE AND FOUND STAINS.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8243762. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2018-09-26. MEDICAL DEVICE LOT #: 8243752. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2018-09-25. MEDICAL DEVICE LOT #: 8305758. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2018-11-26. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD CONNECTA¿ STOPCOCK HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OPERATING ROOM OPENED THE PACKAGE AND FOUND STAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182478 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other