BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 16138557 · Received January 11, 2023

    Report

    Report Number
    1911916-2023-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    October 26, 2022
    Report Date
    January 22, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    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

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A BLUE PARTICLE IN THE SYRINGE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH NO PACKAGING BLISTER. THERE IS A BLUE COLOR FOREIGN MATTER ADHERED OR EMBEDDED TO THE INNER WALL OF THE SYRINGE AND IS LOCATED TOWARDS THE BOTTOM PART OF THE SYRINGE BARREL. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 1091423. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FAILURE OCCURRED ON (B)(6) 2022, DURING INTERNAL MANUFACTURING WHERE THE OPERATOR NOTICED A BLUE PARTICLE IN THE SYRINGE. THE BLUE PARTICLE WAS OBSERVED INSIDE THE SYRINGE NEAR THE BOTTOM OF THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FAILURE OCCURRED ON (B)(6) 2022, DURING INTERNAL MANUFACTURING WHERE THE OPERATOR NOTICED A BLUE PARTICLE IN THE SYRINGE. THE BLUE PARTICLE WAS OBSERVED INSIDE THE SYRINGE NEAR THE BOTTOM OF THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420280 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 1091423 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown