BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 17786458 · Received September 20, 2023

    Report

    Report Number
    1911916-2023-00677
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 27, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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: 21-SEP-2023. H6: INVESTIGATION SUMMARY IT WAS REPORTED THE SYRINGE FILLS BEYOND THE 30ML TO APPROXIMATELY 31-32ML. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AD ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE ZERO LINE IS CORRECT, AND THE SCALE PRINTING IS GOOD. VOLUMETRIC ACCURACY WAS TESTED, AND THE SAMPLE PASSED. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOTS 2179699, 2152784, 2210109, 2179725, 2243867 AND 2152755. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED, AND A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2179699. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2027. H4. DEVICE MANUFACTURE DATE: 28JUN2022. D4. MEDICAL DEVICE LOT #: 2152784. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2027. H4. DEVICE MANUFACTURE DATE: 01JUN2022. D4. MEDICAL DEVICE LOT #: 2210109. D4. MEDICAL DEVICE EXPIRATION DATE: 31JUL2027. H4. DEVICE MANUFACTURE DATE: 29JUL2022. D4. MEDICAL DEVICE LOT #: 2179725. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2027. H4. DEVICE MANUFACTURE DATE: 28JUN2022. D4. MEDICAL DEVICE LOT #: 2243867. D4. MEDICAL DEVICE EXPIRATION DATE: 31AUG2027. H4. DEVICE MANUFACTURE DATE: 31AUG2022. D4. MEDICAL DEVICE LOT #: 2152755. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAY2027. H4. DEVICE MANUFACTURE DATE:01JUN2022. H3. 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 THE BD LUER-LOK¿ TIP SYRING HAS SCALE MARKING ISSUES. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER. THE ISSUE IS WITH THE MARKINGS ON THE BD 30ML SYRINGES. WHEN DRAWING UP FROM A 30ML VIAL, THE BD SYRINGE FILLS BEYOND THE 30ML TO APPROXIMATELY 31-32 MLS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD LUER-LOK¿ TIP SYRING HAS SCALE MARKING ISSUES. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER. THE ISSUE IS WITH THE MARKINGS ON THE BD 30ML SYRINGES. WHEN DRAWING UP FROM A 30ML VIAL, THE BD SYRINGE FILLS BEYOND THE 30ML TO APPROXIMATELY 31-32 MLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997758 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown