BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 16907176 · Received May 10, 2023

    Report

    Report Number
    1213809-2023-00487
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 16, 2023
    Report Date
    June 7, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096466
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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: 09-MAY-2023. INVESTIGATION SUMMARY: SEVEN SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES WERE TESTED FOR LEAKAGE, AND ALL WERE FOUND TO BE ACCEPTABLE PER PRODUCT SPECIFICATION. BASED ON THE INVESTIGATION WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3017631, D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2027, H4. DEVICE MANUFACTURE DATE: 17-JAN-2023; D4. MEDICAL DEVICE LOT #: 2348176, D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027, H4. DEVICE MANUFACTURE DATE: 14-DEC-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD LUER-LOK¿ SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 23 - FOUR BD 5 ML LUER-LOK SYRINGES (REF (B)(4), LOT 3017631, EXP 2027-12-31). AND THREE BD 5 ML LUER-LOK SYRINGES (REF (B)(4), LOT 2348176, EXP 2027-11-30) SEVEN (TOTAL) BD 5 ML SYRINGES LEAKING FROM BLACK PLUNGER WHEN ASSOCIATE WITHDRAWING 5 ML OF FENWAL ANTICOAGULANT SODIUM CITRATE SOLUTION USP (NDC 0942-9504-10, LOT 408745, EXP MAY 24). NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD LUER-LOK¿ SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023 - FOUR BD 5 ML LUER-LOK SYRINGES (REF 309646, LOT 3017631, EXP 2027-12-31) AND THREE BD 5 ML LUER-LOK SYRINGES (REF 309646, LOT 2348176, EXP 2027-11-30) SEVEN (TOTAL) BD 5 ML SYRINGES LEAKING FROM BLACK PLUNGER WHEN ASSOCIATE WITHDRAWING 5 ML OF FENWAL ANTICOAGULANT SODIUM CITRATE SOLUTION USP (NDC 0942-9504-10, LOT 408745, EXP MAY 24). NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231525 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903096466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown