BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN

    MDR report key: 20374495 · Received October 4, 2024

    Report

    Report Number
    9610847-2024-00299
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    July 28, 2024
    Report Date
    November 7, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833238
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383323 AND LOT NUMBER 2062110. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN RETRACTION FAILED. JULY 28, 2024 PATIENT FOR CHECKING THE CHEST / LUNG SCAN + CTPA, TO RULE OUT PULMONARY EMBOLISM, TO THE PATIENT BEFORE THE EXAMINATION OF THE RETENTION OF BLUE INDWELLING NEEDLE BACKUP INSPECTION REQUIRES THE USE OF CLOSED TIP AUTO-RETRACTION TYPE INDWELLING NEEDLE, DURING THE USE OF THE OPERATOR FOUND THAT THE PRODUCT PUNCTURE PROCESS OF THE TIP OF THE NEEDLE CAN NOT BE AUTOMATICALLY RETRACTED, AND CAN NOT CONTINUE TO USE THE IMPACT ON THE DIAGNOSIS AND TREATMENT WORK, DID NOT CAUSE HARM TO THE PATIENT, THE DEPARTMENT IMMEDIATELY DISCONTINUED TO REPLACE THE SAME TYPE OF EQUIPMENT AND NOTIFY THE RELEVANT DEPARTMENTS TO DEAL WITH.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699055 BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2062110 00382903833238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown