BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION SET (C50)

    MDR report key: 8744128 · Received June 28, 2019

    Report

    Report Number
    3003152976-2019-00429
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 12, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION IS AS FOLLOWS: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON REVIEWING THE PHOTO, IT WAS VERIFIED THE CONNECTOR WAS NOT ATTACHED TO THE DRIP CHAMBER. A DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF LOT K71646-1. THE FINAL PRODUCT FOR LOT K71646-1 IS ASSEMBLED AND PACKAGED AT A SUPPLIER SITE. WE NOTIFIED THE SUPPLIER OF THE REPORTED ISSUE AND PROVIDED THE PHOTO FOR EVALUATION. THE ASSEMBLY OF THE CONNECTOR TO THE CHAMBER IS A MANUAL PROCESS WHICH IS COMPLETED PRIOR TO ASSEMBLING THE TUBING. THROUGH THEIR INVESTIGATION IT WAS DETERMINED THAT THIS ISSUE LIKELY OCCURRED AS HUMAN ERROR. THE OPERATOR LIKELY OVERLOOKED THIS TASK AND DID NOT PROPERLY IDENTIFY THE MISSING CONNECTOR BEFORE THE ITEM WAS PACKAGED. IT IS BELIEVED THIS IS AN ISOLATED INCIDENT THAT IS UNLIKELY TO REOCCUR. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. CONCLUSION(S): THE FINAL PRODUCT SECONDARY SET C50 IS NOT ASSEMBLED/PACKAGED IN SAN AGUSTÍN FACILITIES. THE INFORMATION OF THIS COMPLAINT WAS SENT TO THE SUBCONTRACTOR (CODAN) TO PERFORM THE INVESTIGATION (SC-058-19). ACCORDING TO THEIR REPORT, THE DEFECT SEEMS TO BE CAUSED BY A HUMAN ERROR. THE ASSEMBLY OF THE DRIP CHAMBER AND CARMEL ADAPTER WAS A MANUAL PROCESS. APPARENTLY, OPERATOR OVERLOOKED THE ASSEMBLY OF THE ADAPTER DUE TO A HUMAN ERROR. THE FAULT IS CONSIDERED AS AN ISOLATED CASE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MISSING CONNECTOR WITH A BD PHASEAL¿ INFUSION SET (C50) BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONNECTOR PART WAS NOT IN THE PACKAGING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MISSING CONNECTOR WITH A BD PHASEAL¿ INFUSION SET (C50) BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONNECTOR PART WAS NOT IN THE PACKAGING."

    Additional Manufacturer Narrative · 1

    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 THERE WAS A MISSING CONNECTOR WITH A BD PHASEAL¿ INFUSION SET (C50) BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONNECTOR PART WAS NOT IN THE PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536526 BD PHASEAL¿ INFUSION SET (C50) INFUSION SET LHI BECTON DICKINSON, S.A. K71646-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other