BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ MICRO BORE EXTENSION SET

    MDR report key: 12507618 · Received September 21, 2021

    Report

    Report Number
    9610847-2021-00459
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 25, 2021
    Report Date
    November 4, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851028
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTOS. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD Q-SYTE¿ MICRO BORE EXTENSION SET THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: " LOT NUMBER 1082699: AFTER TAKING BLOOD THROUGH THE SPLIT SEPTUM, THE BLOOD LEAKED OUT OF THE LOCK (NOT FROM THE SPLIT SEPTUM). LOT 1021726: BLOOD LEAKED AFTER CONNECTION TO THE CATHETER; NO BLOOD WAS TAKEN FROM THIS LOCK; LEAKAGE IN THE SAME PLACE AS LOT 1082699. THE LOCK HAD NOT YET BEEN USED FOR DRUG ADMINISTRATION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1082699. MEDICAL DEVICE EXPIRATION DATE: 2026-03-31. DEVICE MANUFACTURE DATE: 2021-04-28. MEDICAL DEVICE LOT #: 1021726. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-03-01. 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 WHEN USING THE BD Q-SYTE¿ MICRO BORE EXTENSION SET THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: " LOT NUMBER 1082699: AFTER TAKING BLOOD THROUGH THE SPLIT SEPTUM, THE BLOOD LEAKED OUT OF THE LOCK (NOT FROM THE SPLIT SEPTUM). LOT 1021726: BLOOD LEAKED AFTER CONNECTION TO THE CATHETER; NO BLOOD WAS TAKEN FROM THIS LOCK; LEAKAGE IN THE SAME PLACE AS LOT 1082699. THE LOCK HAD NOT YET BEEN USED FOR DRUG ADMINISTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401195 BD Q-SYTE¿ MICRO BORE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385102 SEE H.10 30382903851028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown