BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD

    MDR report key: 10411635 · Received August 14, 2020

    Report

    Report Number
    1911916-2020-00742
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. (B)(4). INVESTIGATION SUMMARY: THIRTY-TWO PHOTOS WERE PROVIDED FOR EVALUATION. THE PHOTOS SHOW A NEEDLE TIP WITH DISCOLORATION. PER THE TW RECORDS, THE ANALYSIS OF THE SAMPLES WILL BE PERFORMED BY THE CUSTOMER AND PROVIDE THE REPORT. THIS IS THE 1ST COMPLAINT FOR LOT # 9130964 FOR THIS TYPE OF DEFECT OR SYMPTOM. 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. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THE SOURCE OF THE SYMPTOM IS UNKNOWN. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE NS 27 GA 1 IN BLT SQ GRD W/O SHLD HAD FOREIGN MATTER AND THE NEEDLE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301643, BATCH NO.: 9130964. DESCRIPTION OF COMPLAINT: DURING THE IN-PROCESS QC INSPECTION, OUR TECHNICIAN FOUND TWO NON-CONFORMING CANNULAS: ONE-PIECE HAS A NICK/RAISED METAL AT THE TIP AND ONE-PIECE HAS FM AT THE TIP. THIS SAMPLE REPRESENTS DISCOLORED FM AT THE TIP, PLEASE SEE THE IMAGES BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870239 NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9130964

    Patients

    Seq Age Sex Outcome Treatment
    1 Other