BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR LE MULTIPAK (2-60ML SYRINGES, 90" Y TUBIN

    MDR report key: 16974163 · Received May 22, 2023

    Report

    Report Number
    1518293-2023-00011
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Report Date
    April 24, 2023
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K984088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY A COMPLAINT WAS RECEIVED ON PART 801800 LOT C017352G ALLEGING THE FRONT OF THE SYRINGE DISLODGED WHILE INJECTING AT 2ML/S WITH A PATIENT CONNECTED DURING THE PROCEDURE. ONLY THE DRUG LEAKED FROM THE TUBING LINE AND THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OTHER THAN AN INCOMPLETE PROCEDURE. PICTURES WERE RECEIVED WITH THE COMPLAINT SHOWING THE LUER THREADS HAD BECOME DETACHED FROM THE SYRINGE DURING THE INJECTION. THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING SITE FOR NOTIFICATION. THE LOT IN QUESTION WAS MANUFACTURED IN APRIL OF 2020. THE UNIT WAS USED 24APR2023 AND THE LOT EXPIRED 27APR2023. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED. SOME POTENTIAL CAUSES FOR BROKEN AND/OR DAMAGED LUER THREADS INCLUDES DAMAGE THAT MAY HAVE OCCURRED DURING MANUFACTURING WHEN BARRELS ARE TRANSFERRED FROM ONE STATION TO THE NEXT WHEN THE PART COMES INTO CONTACT WITH ANOTHER PART. ANOTHER POTENTIAL CAUSE MAY BE DUE TO INTRODUCTION OF COMPONENTS INTO THE SYRINGE ASSEMBLY STATION IF PARTS ARE MISALIGNED WHEN THEY ARE ADVANCED. THIS CAN OCCUR DUE TO TIMING OF PARTS SUPPLIED. THERE ARE HIGH AND LOW PARTS SENSORS ON EACH AIR GLIDE TUBE AT EACH TRANSFER STATION WHICH ARE MONITORED AND ADJUSTED AS NEEDED DURING EACH SHIFT OF PRODUCTION. A THIRD POSSIBILITY IS THAT AN OCCLUSION IN THE TUBING CREATED A BUILDUP OF PRESSURE, WHICH THEN CAUSE THE SEPARATION OF THE LUER THREADS FROM THE SYRINGE. RETAINED SAMPLES WERE ALSO REVIEWED. TWO SYRINGES WERE CONNECTED TO AN OPTISTAR ELITE TEST INJECTOR AND WERE TESTED AT VARIOUS FLOW RATES PROGRAMMED UP TO 8ML/SEC. NEITHER SYRINGE EXPERIENCED THE COMPLAINT CONDITION. A THIRD SYRINGE WAS ABLE TO BE MADE TO FAIL AT THE LUER THREADS BY EXHIBITING EXCESSIVE FORCE ONTO THE LATERAL FLOW NEEDLE AT AN ANGLE PERPENDICULAR TO THE SYRINGE. PER THE CURRENT INVESTIGATION, THERE IS NOT ENOUGH EVIDENCE TO CONFIRM THE REPORTED CONDITIONS TO BE MANUFACTURING-RELATED. COMPLAINT TRENDS ARE EVALUATED DURING A MONTHLY MEETING TO DETERMINE IF A FORMAL CORRECTIVE/PREVENTATIVE ACTION (CAPA) IS WARRANTED. AT THIS TIME, THERE IS NOT ENOUGH INFORMATION TO ESCALATE THE COMPLAINT TO A CAPA. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS THAT THREE (3) COMPLAINTS ON THIS LOT WERE RECEIVED TOGETHER IN THE PAST, ONE (1) OF WHICH WAS FOR A SIMILAR ISSUE ON ONE (1) UNIT. REFERENCE COMPLAINT (B)(4). IMPACT ASSESSMENT SUMMARY. THE PROCEDURE WAS NOT COMPLETED, BUT THERE WERE NO NEGATIVE IMPACTS TO THE PATIENT OR USERS REPORTED. IMDRF CODES = B02, B14; C070603; D02. ROOT / PROBABLE CAUSE CODE. UNKNOWN. ROOT / PROBABLE CAUSE SUMMARY. SEE INVESTIGATION SUMMARY FOR DETAILS INTO POSSIBLE ROOT CAUSES. WITHOUT THE UNIT RETURNED, A DEFINITIVE ROOT CAUSE IS NOT POSSIBLE TO IDENTIFY. THERE IS NO NEED FOR A CAPA AT THIS TIME. THESE ISSUES ARE REPORTED UPON DURING MANAGEMENT REVIEWS TO CONSIDER INPUT FOR CORRECTIVE ACTION. QA WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. DISPOSITION SUMMARY. THE LOT EXPIRED 27APR2023 AND IS NO LONGER ABLE TO BE USED.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN BEIJING, CHINA ON (B)(6) 2023. 801800 SYRINGE, THE FRONT PART DISLODGED WHILE INJECTING USING 2ML/S INJECTION RATE, THE LINE WAS CONNECTED TO THE PATIENT'S ARM AT THIS TIME, BUT ONLY THE DRUG LEAKED AND SPLASHED WHEN THE FAILURE OCCURRED, THE PATIENT WAS NOT INJURED AND LEFT AFTER RE-CHECKING. PATIENT WAS CONNECTED, PROCEDURE NOT COMPLETED. FACILITY TERMINATED THE PATIENT FOR FURTHER SCANNING BECAUSE NOT ENOUGH CONTRAST MEDIA WAS GETTING INTO THE BODY, PLUS THE GADOLINIUM WAS SPRAYING EVERYWHERE AND INTERFERING WITH THE NEXT SCAN. NO OTHER CLINICAL CONSEQUENCES. NO PATIENT OR OCCUPATIONAL EXPOSURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647417 OPTISTAR LE MULTIPAK (2-60ML SYRINGES, 90" Y TUBIN OPTISTAR LE MULTIPAK (2-60ML SYRINGES, 90" Y TUBIN DXT LIEBEL-FLARSHEIM 801800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown