BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 12291538 · Received August 6, 2021

    Report

    Report Number
    1911916-2021-00793
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 29, 2021
    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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0022124 , MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-01-22. MEDICAL DEVICE LOT #: 9226950, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-08-14. MEDICAL DEVICE LOT #: 9226952, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-08-14. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBERS 0022124, 9226950 AND 9226952. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBERS 0022124, 9226950 AND 9226952. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBERS 0022124, 9226950 AND 9226952. 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. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD BLUNT FILL NEEDLES WITH FILTERS EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STAFF BELIEVED THAT THE NEEDLES OF 2 PRODUCTS OF LUCENTIS WERE CONTAMINATED (THE HOSPITAL STAFF FOUND WATER BEADS IN THE NEEDLES AFTER OPENING THE FOLDING BOXES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183087 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 9226952 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1