BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOCK SYRINGE TIP CAP TRAY

    MDR report key: 17035635 · Received May 31, 2023

    Report

    Report Number
    2618282-2023-00040
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BD CARIBE LTD.
    Product Code
    KYW
    UDI-DI
    00382903083411
    PMA / PMN Number
    EXEMPT
    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: 02-JUN-2023 H6: INVESTIGATION SUMMARY FORTY SAMPLES AND PHOTO WERE RECEIVED OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, NO DAMAGE OR MOLDING DEFECT OBSERVED. FURTHER TESTING WAS CONDUCTED, RESULTS FOR DIAMETER MEASUREMENTS OF THE TIP CAPS ARE WITHIN SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2213610, 2234926 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS FOR TIP CAPS, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, AND MANUFACTURING RECORD ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2213610 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2027 H.4. DEVICE MANUFACTURE DATE: 12-SEP-2022 D.4. MEDICAL DEVICE LOT #: 2234926 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027 H.4. DEVICE MANUFACTURE DATE: 01-NOV-2022 H.3. 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 1026 BD¿ TIP CAP TRAY LUER-LOCK SYRINGES EACH FROM LOTS 2213610 AND 2234926 LEAKED. 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 1026 BD¿ TIP CAP TRAY LUER-LOCK SYRINGES EACH FROM LOTS 2213610 AND 2234926 LEAKED. 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?: 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
    1682146 BD¿ LUER-LOCK SYRINGE TIP CAP TRAY LIQUID MEDICATION DISPENSER KYW BD CARIBE LTD. SEE H10 00382903083411

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BD¿ LUER-LOCK SYRINGE TIP CAP TRAY