BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 10399845 · Received August 12, 2020

    Report

    Report Number
    1911916-2020-00735
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 28, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED AND EVALUATED. IT HAS PLASTIC SHIELD. IT HAS NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFICATION LENS FIRST THEN WITH A 30X MICROSCOPE. NO GREEN FOREIGN MATTER WAS OBSERVED. ALSO, ONE PHOTO WAS PROVIDED. IT SHOWS THE SAMPLE RECEIVED. THE NEEDLE IN THE PHOTO HAS THE GREEN FOREIGN MATTER ADHERED TO THE NEEDLE. BASED ON THE INVESTIGATION AND SAMPLE/ PHOTO ANALYSIS, THE SYMPTOM REPORTED BY THE CUSTOMER CAN BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 7200626 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. BASED ON THE INVESTIGATION AND SAMPLE/ PHOTO ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER CAN BE CONFIRMED. THIS LOT WAS PRODUCED FOR 2.95MM UNITS; THEREFORE, THE CPM IS 0.3. WE WILL CONTINUE MONITORING AND TRENDING THIS LOT. ROOT CAUSE DESCRIPTION: A WALK THROUGH WAS DONE LOOKING IN THE MANUFACTURING PROCESS FOR ANY GREEN MATERIAL THAT COULD HAD INDUCE THE SYMPTOM REPORTED BY THE CUSTOMER AND SHOWN IN THE PHOTO; NOTHING WAS OBSERVED OR FOUND; THE PHOTO WAS SHOWN TO THE ASSOCIATES AND COULDN'T THINK OF WHAT THE FM COULD BE OR THE SOURCE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS "GREEN" FOREIGN MATTER ON THE CANNULA WITH A BD BLUNT FILL NEEDLE WITH FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO INFORM YOU ABOUT A COMPLAINT FROM THAI CUSTOMER. THE REASON WAS A GREEN PARTICLE (~1,0MM) STICKING ON THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864020 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 7200626 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other