BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET SN404 W/O BP Y-CONN

    MDR report key: 7768806 · Received August 9, 2018

    Report

    Report Number
    2243072-2018-01093
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 20, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2802211. TAPER GAGE INSPECTION OF COMPLAINT SAMPLE: SBDM INSPECTED THE ADAPTOR TAPER USING GAGE, AND CONCLUDED THE ADAPTOR TO BE WITHIN SPECIFICATION. TAPER GAGE INSPECTION OF HOUSE SAMPLE: SBDM INSPECTED 5 PCS FROM LOT 2802221 FOR ADAPTOR TAPER, AND CONCLUDED THE 5 PCS RETENTION SAMPLES ADAPTER TAPER TO BE WITHIN SPECIFICATION. TAPER GAGE INSPECTION OF ADAPTOR COMPONENT: SBDM INSPECTED 1 LOT (49 PCS) OF ADAPTER COMPONENT FOR TAPER, AND CONCLUDED THE ADAPTORS TAPER TO BE WITHIN SPECIFICATION. DEVICE HISOTRY RECORD REVIEW: SBDM REVIEWED MANUFACTURING RECORD FOR LOT 2802211, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: THE CUSTOMER COMPLAINT RECORD FOR LOT 2802211 WAS REVIEWED AND THERE ARE NO REPEATED ISSUE FROM OTHER CUSTOMERS. INVESTIGATION CONCLUSION: FROM INVESTIGATION OF COMPLAINT SAMPLE, HOUSE SAMPLES, IT WAS CONCLUDED THERE WAS NO ISSUE ON THE ADAPTOR OF THE COMPLAINT SAMPLE. IT WAS ALSO CONCLUDED ADAPTEO COMPONENTS WERE WITHIN TAPER SPECIFICATION AFTER INSPECTION 1 LOT OF 49 PCS. THERE WAS NO ISSUES FROM THE INJECTION MOLDING PROCESS OF ADAPTOR TOO. CORRECTIVE ACTIONS: 1. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET INJECTION MOLDING LINE WORKERS. 2. SBDM WILL IMPLEMENT TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR IV SET MANUFACTURING PROCESS. CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER. D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ IV SET SN404 W/O BP Y-CONN "SEPARATES TOO EASILY", OR HAS A LOOSE CONNECTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ IV SET SN404 W/O BP Y-CONN "SEPARATES TOO EASILY", OR HAS A LOOSE CONNECTION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607545 BD¿ IV SET SN404 W/O BP Y-CONN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2802211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other