BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 17547324 · Received August 14, 2023

    Report

    Report Number
    1213809-2023-00861
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 28, 2023
    Report Date
    September 8, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    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: 23-AUG-2023. INVESTIGATION SUMMARY: ONE SAMPLE AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A GEL-LIKE SUBSTANCE WAS OBSERVED ON THE ROOF OF THE BARREL AND APPEARED TO BE SILICONE LUBRICANT USED IN THE ASSEMBLY PROCESS. THE OBSERVED AMOUNT IS ACCEPTABLE PER PRODUCT SPECIFICATION. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD LIQUID (CONDENSATION) OR GEL TYPE SUBSTANCE IN THEM. REPORT 3 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITAL REPORTER; CUSTOMER REPORTS LIQUID (CONDENSATION) OR GEL TYPE SUBSTANCE IN 10 ML SYRINGE MATERIAL 302995, OCCURRENCES 4, 3 WITH AN UNKNOWN LOT AND LAST OCCURRENCE WITH LOT 3142094. VERBATIM AS FOLLOWS: "GOOD AFTERNOON, FRIDAY, I ENCOUNTERED SOMETHING ODD I HAVE NOT SEEN BEFORE. SOME 10ML SYRINGES APPEARED TO HAVE A LIQUID (CONDENSATION) OR GEL TYPE SUBSTANCE IN THEM. I NOTICED IT WHEN I PULLED THE PLUNGER BACK. THE FIRST 2 I FOUND I THOUGHT WAS JUST ODD (BOTH ON THE SAME PATIENT) AND I THREW THEM AWAY. I FOUND A 3RD ONE, BUT HAD OPENED OTHER 10ML SYRINGES SO I WASN¿T SURE WHICH LOT IT HAD COME FROM (I HAD ALREADY THROWN THE PACKAGE THAT WAS LABELED IN THE TRASHCAN SO I COULDN¿T BE SURE WHICH BELONGED TO THAT SYRINGE). IT HAPPENED A 4TH TIME SO I DO HAVE THE SYRINGE AND THE PACKAGING FOR THAT ONE. ARE YOU ABLE TO RECONFIRM THE FIRST 2 DEFECTIVE SYRINGES WERE FOR 1ST PATIENT/INCIDENT, THE THIRD SYRINGE FOR THE 2ND PATIENT/INCIDENT AND FOURTH SYRINGE FOR THE 3RD PATIENT/INCIDENT? YES. WHAT WAS THE PATIENT OUTCOME? INCIDENT DID NOT REACH PATIENT. WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD LIQUID (CONDENSATION) OR GEL TYPE SUBSTANCE IN THEM. REPORT 3 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITAL REPORTER; CUSTOMER REPORTS LIQUID (CONDENSATION) OR GEL TYPE SUBSTANCE IN 10 ML SYRINGE MATERIAL 302995, OCCURRENCES 4, 3 WITH AN UNKNOWN LOT AND LAST OCCURRENCE WITH LOT 3142094. VERBATIM AS FOLLOWS: "GOOD AFTERNOON, FRIDAY, I ENCOUNTERED SOMETHING ODD I HAVE NOT SEEN BEFORE. SOME 10ML SYRINGES APPEARED TO HAVE A LIQUID (CONDENSATION) OR GEL TYPE SUBSTANCE IN THEM. I NOTICED IT WHEN I PULLED THE PLUNGER BACK. THE FIRST 2 I FOUND I THOUGHT WAS JUST ODD (BOTH ON THE SAME PATIENT) AND I THREW THEM AWAY. I FOUND A 3RD ONE, BUT HAD OPENED OTHER 10ML SYRINGES SO I WASN¿T SURE WHICH LOT IT HAD COME FROM (I HAD ALREADY THROWN THE PACKAGE THAT WAS LABELED IN THE TRASHCAN SO I COULDN¿T BE SURE WHICH BELONGED TO THAT SYRINGE). IT HAPPENED A 4TH TIME SO I DO HAVE THE SYRINGE AND THE PACKAGING FOR THAT ONE. ARE YOU ABLE TO RECONFIRM THE FIRST 2 DEFECTIVE SYRINGES WERE FOR 1ST PATIENT/INCIDENT, THE THIRD SYRINGE FOR THE 2ND PATIENT/INCIDENT AND FOURTH SYRINGE FOR THE 3RD PATIENT/INCIDENT? YES. WHAT WAS THE PATIENT OUTCOME? INCIDENT DID NOT REACH PATIENT WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737640 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3142094 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown