BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NOKOR¿ FILTER NEEDLE

    MDR report key: 17487721 · Received August 9, 2023

    Report

    Report Number
    1911916-2023-00568
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    May 25, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052004
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24AUG2023. H6: INVESTIGATION SUMMARY. IT WAS REPORTED THERE IS FOREIGN MATTER IN THE BD SHARP FILTER NEEDLES. TO AID IN THE INVESTIGATION, FIVE SAMPLES IN SEALED PACKAGING BLISTERS AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. NO FOREIGN MATTER OF ANY KIND WAS DETECTED IN THE RETURNED SAMPLES. IN THE PHOTOS PROVIDED, TWO PHOTOS SHOW PACKAGING BLISTERS WITH NEEDLE ASSEMBLIES. THE NEEDLE ASSEMBLIES HAVE SPECKS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE ADDITIONAL PHOTO SHOWS A DOCUMENT WITH INFORMATION REGARDING BATCH NUMBERS, ACCEPTABLE QUALITY LIMITS AND QUANTITIES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305200, LOT 2082200. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT A DEFECTIVE SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT 48000 BD NOKOR¿ FILTER NEEDLES HAD BLACK FOREIGN MATTER EMBEDDED IN THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE (B)(4) RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS ENCOUNTERED FOREIGN MATTER IN THE BD SHARP FILTER NEEDLES (BD PART # 305200). THIS IMPACTS BD LOT NUMBERS: LOT 2172524 (B)(4) PIECES). LOT 2082200 (B)(4) PIECES). ADDITIONAL INFORMATION FROM CUSTOMER RESPONSE ON 08-03-2023. ARE YOU ABLE TO PROVIDE THE DATE OF THE EVENT IN FORMAT DD-MMM-YYYY? LOT 2172524: 25-MAY-2023. LOT 2082200: 21-JUN-2023. ARE YOU ABLE TO DESCRIBE THE FOREIGN MATTER FOR LOT #2172524 AND LOT # 2082200, EITHER THE FOREIGN MATTER PLACED IN CAP AREA ONLY OR IN NEEDLES/ANY FLUID PATH COMPONENT? LOT 2172524 WITH BLACK DOTS. LOT 2082200 WITH WHITE FOREIGN MATTER IN NEEDLE HUB DOWNSTREAM OF FILTER. WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? ISSUE WAS NOTED BEFORE USE. WAS THERE ANY PATIENT INVOLVEMENT? NO. THIS EVENT WAS INITIATED PRIOR TO CO-PACKAGING AND LABELING. WHAT WAS THE PATIENT OUTCOME? N/A. NO FILTER NEEDLES FROM THESE LOTS HAVE BEEN SHIPPED TO HCP¿S FOR ADMINISTRATION. WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO. ALL UNITS FROM THESE LOTS HAVE BEEN PLACED IN QC HOLD PRIOR TO CO-PACKAGING WITH THE DRUG PRODUCT. NO DEFECTIVE UNITS HAVE BEEN SHIPPED TO THE HCP FOR ADMINISTRATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 48000 BD NOKOR¿ FILTER NEEDLES HAD BLACK FOREIGN MATTER EMBEDDED IN THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS ENCOUNTERED FOREIGN MATTER IN THE BD SHARP FILTER NEEDLES (BD PART # 305200). THIS IMPACTS BD LOT NUMBERS: LOT 2172524 (48,000 PIECES). LOT 2082200 (120,000 PIECES). ADDITIONAL INFORMATION FROM CUSTOMER RESPONSE ON (B)(6) 2023. ARE YOU ABLE TO PROVIDE THE DATE OF THE EVENT INFORMAT DD-MMM-YYYY? LOT 2172524: (B)(6) 2023. LOT 2082200: (B)(6) 2023. ARE YOU ABLE TO DESCRIBE THE FOREIGN MATTER FOR LOT #2172524 AND LOT # 2082200, EITHER THE FOREIGN MATTER PLACED IN CAP AREA ONLY OR IN NEEDLES/ANY FLUID PATH COMPONENT? LOT 2172524 WITH BLACK DOTS. LOT 2082200 WITH WHITE FOREIGN MATTER IN NEEDLE HUB DOWNSTREAM OF FILTER. WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? ISSUE WAS NOTED BEFORE USE. WAS THERE ANY PATIENT INVOLVEMENT? NO. THIS EVENT WAS INITIATED PRIOR TO CO-PACKAGING AND LABELING. WHAT WAS THE PATIENT OUTCOME? N/A. NO FILTER NEEDLES FROM THESE LOTS HAVE BEEN SHIPPED TO HCP¿S FOR ADMINISTRATION. WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO. ALL UNITS FROM THESE LOTS HAVE BEEN PLACED IN QC HOLD PRIOR TO CO-PACKAGING WITH THE DRUG PRODUCT. NO DEFECTIVE UNITS HAVE BEEN SHIPPED TO THE HCP FOR ADMINISTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688492 BD NOKOR¿ FILTER NEEDLE NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 2172524 00382903052004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown