BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE

    MDR report key: 17034274 · Received May 31, 2023

    Report

    Report Number
    1213809-2023-00583
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 13-JUN-2023. INVESTIGATION SUMMARY: FORTY SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED ON THE SYRINGE TIPS. FURTHERMORE, THE TIPS WERE MEASURED USING A VALIDATED MEASUREMENT METHOD PER INTERNAL PROCEDURE AND YIELDED ACCEPTABLE RESULTS. SINCE THE SAMPLES RECEIVED WERE ACCEPTABLE PER PRODUCT SPECIFICATION AND DID NOT DISPLAY THE REPORTED CONDITION A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2131710. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. DEVICE MANUFACTURE DATE: 11-MAY-2022. MEDICAL DEVICE LOT #: 2250337. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. DEVICE MANUFACTURE DATE: 07-SEP-2022. MEDICAL DEVICE LOT #: 2250336. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. DEVICE MANUFACTURE DATE: 07-SEP-2022. 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 THAT 137 BD¿ LUER SLIP TIP SYRINGES EACH FROM LOTS 2131710, 2250337, AND 2250336 LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER COMPLAINED ABOUT SYRINGE LEAKAGE. TIP CAPS ARE NOT SECURELY TIGHT ON 1ML BD SYRINGE CAUSING LEAKAGE. PATIENT INJURY? (Y/N) NO... 2. ARE YOU ABLE TO PROVIDE THE NUMBER OF DEFECTIVE SYRINGES THAT WAS FOUND DURING THE INCIDENT? WE DO NOT KNOW THE DEFECT. WHERE THE LEAKAGE IS COMING FROM. 3. WAS THIS INCIDENT NOTED BEFORE USE OR DURING/AFTER USE? DURING USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 137 BD¿ LUER SLIP TIP SYRINGES EACH FROM LOTS 2131710, 2250337, AND 2250336 LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER COMPLAINED ABOUT SYRINGE LEAKAGE. TIP CAPS ARE NOT SECURELY TIGHT ON 1ML BD SYRINGE CAUSING LEAKAGE. PATIENT INJURY? (Y/N) NO. ARE YOU ABLE TO PROVIDE THE NUMBER OF DEFECTIVE SYRINGES THAT WAS FOUND DURING THE INCIDENT? WE DO NOT KNOW THE DEFECT. WHERE THE LEAKAGE IS COMING FROM. WAS THIS INCIDENT NOTED BEFORE USE OR DURING/AFTER USE? DURING USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030811 BD¿ LUER SLIP TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown