BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16882373 · Received May 5, 2023

    Report

    Report Number
    1911916-2023-00278
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 15, 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
    CA, 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: 10-MAY-2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED SMALL FLECKS WILL DISPENSE FROM THE SYRINGE. TO AID IN THE INVESTIGATION, TWO SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH A 10X MAGNIFIER LENS, AND THEN WITH A 30X MICROSCOPE. NO FOREIGN MATTER OF ANY KIND WAS FOUND, AND NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS A CONTAINER WITH CRYSTALLINE SOLUTION OVER WHAT APPEARS TO BE A WHITE SQUARE SHAPED FILTER. ONE FILTER APPEARS TO HAVE A BLACK SPECK. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 2243241. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT 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 THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 THAT SMALL FLECKS WILL DISPENSE FROM EACH BD LUER-LOK¿ TIP SYRINGE. THIS OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WE PURCHASED 6 PACKS OF "BD SYRING 50CC LUER-LOK. 40PKRX" (MFPN# 309653 LOT# 2243241) ON 11/17/2022, AND WHEN RECENTLY USING THE MATERIAL, WE DISCOVERED SMALL FLECKS WILL DISPENSE FROM EACH SYRINGE DURING USAGE. WE HAVE ONLY USED 2 SYRINGES OUT OF THE 240 PIECES THAT WERE DELIVERED IN THE 6 PACKS AND WERE WONDERING IF IT IS STILL POSSIBLE TO REQUEST A NEW BATCH TO REPLACE LOT# 2243241. ATTACHED TO THIS EMAIL IS THE PACKING SLIP AND PLEASE LET ME KNOW IF YOU NEED ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMALL FLECKS WILL DISPENSE FROM EACH BD LUER-LOK¿ TIP SYRINGE. THIS OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WE PURCHASED 6 PACKS OF "BD SYRING 50CC LUER-LOK 40PKRX" (MFPN# 309653 LOT# 2243241) ON (B)(6)2022, AND WHEN RECENTLY USING THE MATERIAL, WE DISCOVERED SMALL FLECKS WILL DISPENSE FROM EACH SYRINGE DURING USAGE. WE HAVE ONLY USED 2 SYRINGES OUT OF THE 240 PIECES THAT WERE DELIVERED IN THE 6 PACKS AND WERE WONDERING IF IT IS STILL POSSIBLE TO REQUEST A NEW BATCH TO REPLACE LOT# 2243241. ATTACHED TO THIS EMAIL IS THE PACKING SLIP AND PLEASE LET ME KNOW IF YOU NEED ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212349 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 2243241 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown