BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CATHETER TIP 60ML

    MDR report key: 12006112 · Received June 15, 2021

    Report

    Report Number
    1911916-2021-00558
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    KYZ
    UDI-DI
    00382903096206
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THE WHOLE CATHETER TIP OF THE SYRINGE IS DISCOLORED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE CAP WAS REMOVED AND IS CLEAR. THE SYRINGE BARREL CATHETER TIP HAS DISCOLORATION. WE TRIED TO REMOVE IT WITH ALCOHOL AND IT WAS NOT POSSIBLE. IT IS EMBEDDED DEGRADED RESIN. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309620, LOT NUMBER 0062238. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. FREQUENCY OF INSPECTIONS WAS INCREASED TO MITIGATE THE RISK OF THESE ESCAPES. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE. MOLDING PROCESS. THE EMBEDDED DEGRADED RESIN OCCURS AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. THE INSPECTION FREQUENCY WAS INCREASED TO MITIGATE THE RISK OF THESE ESCAPES. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE CATHETER TIP 60ML CATHETER TIP WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHOLE CATHETER TIP OF SYRINGE DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893992 SYRINGE CATHETER TIP 60ML IRRIGATING SYRINGE KYZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 0062238 00382903096206

    Patients

    Seq Age Sex Outcome Treatment
    1