BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 10578298 · Received September 24, 2020

    Report

    Report Number
    9610847-2020-00296
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    September 2, 2020
    Report Date
    October 2, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 8305758, 8243762, AND 8121546. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, EXCESS SILICONE WAS OBSERVED. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM AN ERROR IN THE AMOUNT OF SILICONE DISPERSED WITHIN THE MANUFACTURING PROCESS. A CHANGE WAS INITIATED TO PLACE A SILICONE SENSOR WITHIN THE DISPENSER MACHINERY TO PREVENT THIS TYPE OF ISSUE FROM RECURRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 500 BD CONNECTA¿ STOPCOCKS EXPERIENCED DISCOLORED BLISTER PACKS WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE OUTER PACKAGE IS INTACT AND UNDAMAGED, THE SMALLEST PACKAGE CONTAMINATION IS FOUND DURING USE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8305758, MEDICAL DEVICE EXPIRATION DATE: 2021-10-31, DEVICE MANUFACTURE DATE: 2018-11-26, MEDICAL DEVICE LOT #: 8121546, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-07-11, MEDICAL DEVICE LOT #: 8243762, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2018-09-26.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 500 BD CONNECTA¿ STOPCOCKS EXPERIENCED DISCOLORED BLISTER PACKS WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE OUTER PACKAGE IS INTACT AND UNDAMAGED, THE SMALLEST PACKAGE CONTAMINATION IS FOUND DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043155 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other