BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FILTER BLUNT FILL NEEDLE

    MDR report key: 16826952 · Received April 27, 2023

    Report

    Report Number
    1911916-2023-00256
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    February 17, 2023
    Report Date
    April 12, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903052110
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER WAS NOT REPORTED; HOWEVER, A POTENTIAL LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THAT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1027270. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2026, DEVICE MANUFACTURE DATE: 06-AUG-2021. MEDICAL DEVICE LOT #: 1120211. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. DEVICE MANUFACTURE DATE: 28-SEP-2021. MEDICAL DEVICE LOT #: 1144587. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026. DEVICE MANUFACTURE DATE: 29-NOV-2021. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A BLACK FOREIGN MATTER IN A SYRINGE. TO AID IN THE INVESTIGATION, SIX PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS FOUR VIALS, TWO FILTER NEEDLES WITH THE SHIELD, AND A SYRINGE WITH A NEEDLE ASSEMBLY CONNECTED TO IT. THE NEEDLE ASSEMBLY HAS A YELLOW NEEDLE HUB AND A SPECK LOCATED AT THE BOTTOM OF THE SHIELD. IT IS NOT CLEAR IF THE SPECK IS IN THE PLASTIC SHIELD OR NEEDLE HUB. TWO PHOTOS SHOW THE VIALS, AND THE FOURTH PHOTO SHOWS THE FILTER NEEDLES. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED IN THESE PHOTOS. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 30521104, POSSIBLE LOT NUMBERS 1027270, 1120211 AND 1144587. 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. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD FILTER BLUNT FILL NEEDLE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A BLACK FOREIGN MATTER IN A SYRINGE. THE CUSTOMER REPORTED AS FOLLOWS: WHEN THE HCP ASPIRATED EYLEA THROUGH THE DEVICE, A BLACK FOREIGN MATTER WAS FOUND IN THE ASPIRTATED DRUG IN THE SYRINGE. THE HCP DISCONTINUED ITS USE. BAYER ANALYZED THE BLACK FOREIGN MATTER AND FOUND THAT THE MATERIAL WAS SILICONE. POSSIBLE LOT#S: 211216, 211214, OR 210907.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590628 BD FILTER BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown