BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK 1-ML SYRINGE

    MDR report key: 17056329 · Received June 2, 2023

    Report

    Report Number
    8041187-2023-00247
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 14, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 #: 2229394. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. H4. DEVICE MANUFACTURE DATE: 02-SEP-2022. D4. MEDICAL DEVICE LOT #: 2112083. D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. H4. DEVICE MANUFACTURE DATE: 22-APR-2022. D4. MEDICAL DEVICE LOT #: 2141787. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027. H4. DEVICE MANUFACTURE DATE: 21-MAY-2022. D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 26-MAY-2023. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 7 OPENED SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE PAST STOPPER WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE PHOTO SHOWED THAT THERE APPEARED TO BE LEAKAGE. HOWEVER, DURING THE LEAKAGE TESTING OF THE RETURNED SAMPLES NO LEAKAGE WAS OBSERVED. THEREFOR SINCE THE DEFECT WAS NOT OBSERVED DURING THE FUNCTIONAL TESTING, THE REPORTED DEFECT CANNOT BE CONFIRMED. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. PRODUCTION RECORDS WERE REVIEWED, AND THESE BATCHES MEET OUR MANUFACTURING SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD LUER-LOK 1-ML SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THIS IS 2 OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 302149 HAS BEEN USED TO FLUSH PERMACATHS AND CENTRAL LINES AND ON 8 SEPARATE OCCASIONS THE PATIENTS BLOOD HAS FLOWED BACK INTO THE SYRINGE AND HAS GONE PAST THE BLACK STOPPER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD LUER-LOK 1-ML SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THIS IS 2 OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 302149 HAS BEEN USED TO FLUSH PERMACATHS AND CENTRAL LINES AND ON 8 SEPARATE OCCASIONS THE PATIENTS BLOOD HAS FLOWED BACK INTO THE SYRINGE AND HAS GONE PAST THE BLACK STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258118 BD LUER-LOK 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown