BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8608484 · Received May 14, 2019

    Report

    Report Number
    9614033-2019-00149
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 26, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PHYSICAL SAMPLES RECEIVED FOR INVESTIGATION. APPROXIMATELY 100 PIECES WERE RECEIVED AND SENT TO FOR ANALYSIS. IN THE ANALYSIS CARRIED OUT ON CUSTOMER SAMPLES WITH THE APPLICABLE SPECIFICATIONS IN SILICONE AND FOREIGN MATTER CONTENT, IT CAN BE OBSERVED IN SOME OF THE SYRINGES AN APPARENT EXCESS OF SILICONE CONTENT VISUALLY, HOWEVER, ACCORDING TO THE SILICONE CONTENT TEST SAMPLES ARE SATISFACTORY. THE DEFECT FOUND ARE MOLDING DEFECTS THAT ARE NOT ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CUSTOMER. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. DURING THE DOCUMENTARY REVIEW OF THE BATCH NO PROBLEM ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CUSTOMER WAS DETECTED, THE CUSTOMER SAMPLES PRESENTED COMPLIANT RESULTS IN MEDICAL GRADE SILICONE CONTENT WHICH IS THE ONLY LIQUID THAT IS INTRODUCED INTO THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THERE IS AN OILY SUBSTANCE ON THE INSIDE AND OUTSIDE OF THE BARREL ON SEVERAL SYRINGES. PER CUSTOMER EMAIL: THANK YOU FOR YOUR SWIFT COMMUNICATION REGARDING THE ¿OILY SUBSTANCE¿ ON 3ML SYRINGES REPORTED FROM THE CATH LAB AT. I WILL BE ASSISTING IN GATHERING INFORMATION, AND OUR PRODUCT INVESTIGATION TEAM WILL CONDUCT A THOROUGH REVIEW OF INFORMATION AND PROVIDE A REPORT ON THIS PRODUCT. WAS ANYONE INJURED WHILE USING THE PRODUCT PATIENT AND/OR CLINICIAN/S? UNKNOWN. TO BE DETERMINED WAS THIS PRODUCT USED ON A PATIENT? UNKNOWN. YES, MANY IS THERE ANY PRODUCT REMAINING FROM THE INVOLVED LOT? YES ¿ THE LOT NUMBER IS 8222925. PULLED FROM CATH LAB. UPON FURTHER INSPECTION - THE OILY SUBSTANCE IS ALSO ON THE INSIDE OF THE BARREL AND AROUND THE EDGE OF THE BLACK PLUNGER ¿ WHICH COMES IN CONTACT WITH WHATEVER IS BEING INJECTED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THERE IS AN OILY SUBSTANCE ON THE INSIDE AND OUTSIDE OF THE BARREL ON SEVERAL SYRINGES. PER CUSTOMER EMAIL: THANK YOU FOR YOUR SWIFT COMMUNICATION REGARDING THE ¿OILY SUBSTANCE¿ ON 3ML SYRINGES REPORTED FROM THE CATH LAB AT. I WILL BE ASSISTING IN GATHERING INFORMATION, AND OUR PRODUCT INVESTIGATION TEAM WILL CONDUCT A THOROUGH REVIEW OF INFORMATION AND PROVIDE A REPORT ON THIS PRODUCT. WAS ANYONE INJURED WHILE USING THE PRODUCT PATIENT AND/OR CLINICIAN/S? UNKNOWN. TO BE DETERMINED WAS THIS PRODUCT USED ON A PATIENT? UNKNOWN. YES, MANY IS THERE ANY PRODUCT REMAINING FROM THE INVOLVED LOT? YES ¿ THE LOT NUMBER IS 8222925. PULLED FROM CATH LAB. **UPON FURTHER INSPECTION - THE OILY SUBSTANCE IS ALSO ON THE INSIDE OF THE BARREL AND AROUND THE EDGE OF THE BLACK PLUNGER ¿ WHICH COMES IN CONTACT WITH WHATEVER IS BEING INJECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403632 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222925 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other