BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION ADAPTER C100-O

    MDR report key: 9775404 · Received March 2, 2020

    Report

    Report Number
    2243072-2020-00309
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    February 6, 2020
    Report Date
    April 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.3. DATE OF EVENT: (B)(6) 2020. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE INFUSION ADAPTER C100-O "FELL OUT" OF THE CHEMO BAG DURING USE WHEN THE CHEMO WAS HUNG. THE CHEMO WAS PREPARED AND KEPT IN THE REFRIGERATOR PRIOR TO ADMINISTRATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD TWO CHEMO SPILLS THIS WEEKEND WHERE WE PREPARED THE BAGS ON FRIDAY FOR ADMINISTRATION OVER THE WEEKEND. WE STORED THEM IN THE REFRIGERATOR UNTIL TIME OF ADMINISTRATION. IN EACH CASE THE INFUSION ADAPTER JUST FELL OUT OF THE BAG WHEN THEY HUNG THE CHEMO." D.1. MEDICAL DEVICE BRAND NAME: INFUSION ADAPTER C100-O. D.2. MEDICAL DEVICE CATALOG#: 515078. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.10. DEVICE AVAILABLE FOR EVAL?: NO. G.2. MANUFACTURING LOCATION: BECTON DICKINSON, S.A. G.5. PMA / 510(K)#: K181221.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: (B)(6) 2020. H.6. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFUSION ADAPTER C100-O "FELL OUT" OF THE CHEMO BAG DURING USE WHEN THE CHEMO WAS HUNG. THE CHEMO WAS PREPARED AND KEPT IN THE REFRIGERATOR PRIOR TO ADMINISTRATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD TWO CHEMO SPILLS THIS WEEKEND WHERE WE PREPARED THE BAGS ON FRIDAY FOR ADMINISTRATION OVER THE WEEKEND. WE STORED THEM IN THE REFRIGERATOR UNTIL TIME OF ADMINISTRATION. IN EACH CASE THE INFUSION ADAPTER JUST FELL OUT OF THE BAG WHEN THEY HUNG THE CHEMO."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD PHASEAL¿ INFUSION ADAPTER "FELL OUT" OF THE CHEMO BAG DURING USE WHEN THE CHEMO WAS HUNG. THE CHEMO WAS PREPARED AND KEPT IN THE REFRIGERATOR PRIOR TO ADMINISTRATION. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD TWO CHEMO SPILLS THIS WEEKEND WHERE WE PREPARED THE BAGS ON FRIDAY FOR ADMINISTRATION OVER THE WEEKEND. WE STORED THEM IN THE REFRIGERATOR UNTIL TIME OF ADMINISTRATION. IN EACH CASE THE INFUSION ADAPTER JUST FELL OUT OF THE BAG WHEN THEY HUNG THE CHEMO."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD PHASEAL¿ INFUSION ADAPTER "FELL OUT" OF THE CHEMO BAG DURING USE WHEN THE CHEMO WAS HUNG. THE CHEMO WAS PREPARED AND KEPT IN THE REFRIGERATOR PRIOR TO ADMINISTRATION. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD TWO CHEMO SPILLS THIS WEEKEND WHERE WE PREPARED THE BAGS ON FRIDAY FOR ADMINISTRATION OVER THE WEEKEND. WE STORED THEM IN THE REFRIGERATOR UNTIL TIME OF ADMINISTRATION. IN EACH CASE THE INFUSION ADAPTER JUST FELL OUT OF THE BAG WHEN THEY HUNG THE CHEMO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241220 INFUSION ADAPTER C100-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other