BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARBY PLASTIC HUB NEEDLE 30GA SHORT

    MDR report key: 20212390 · Received September 13, 2024

    Report

    Report Number
    3002987375-2024-00007
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 7, 2024
    Manufacturer
    SOFIC
    Product Code
    DZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH SUSPECTED DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT IN AN UNSPECIFIED PATIENT OF UNSPECIFIED AGE, SEX, AND MEDICAL HISTORY DURING AN UNSPECIFIED PROCEDURE. THE NEEDLE BROKE OFF AT THE HUB AND THE PATIENT HAD TO HAVE SURGERY TO REMOVE IT. THE DOCTOR HAD FOLLOWED UP WITH PATIENT. PENDING QIR AND FURTHER INFORMATION, NO ROOT CAUSE CAN BE CONCLUDED. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH SUSPECTED DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT IN AN UNSPECIFIED PATIENT OF UNSPECIFIED AGE, SEX, AND MEDICAL HISTORY DURING AN UNSPECIFIED PROCEDURE. THE NEEDLE BROKE OFF AT THE HUB AND THE PATIENT HAD TO HAVE SURGERY TO REMOVE IT. THE DOCTOR HAD FOLLOWED UP WITH PATIENT. PENDING QIR AND FURTHER INFORMATION, NO ROOT CAUSE CAN BE CONCLUDED. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED. MANUFACTURER'S FINAL COMMENTS: THE CLAIMED DEFECTIVE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND THE BATCH RECORDS AND TRACEABILITY DIDN'T SHOW ANY DEVIATION OR EVENT THAT COULD BE RELATED OR HAVE IMPACT ON THE REPORTED ISSUE. QUALITY DEFECT IS THEREFORE EXCLUDED. MANY FACTORS COULD LEAD TO THE REPORTED ISSUE CANNULA BREAKAGE, SUCH AS: - HIGH PRESSURE DURING INJECTION. - CONSTRAINT ON THE CANNULA DURING INJECTION. - UNEXPECTED MOVEMENT DURING INJECTION. - USE OF SEVERAL CARTRIDGES WITH THE SAME NEEDLE (MULTIPLE NEEDLE USE). - BENDING OR STRESSING OF THE CANNULA. - USE OF NEEDLE NOT RECOMMENDED ACCORDING TO THE INJECTION TYPE. - INJECTION ON A HARD SURFACE. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. IN THE RISK TABLE AR028.01, RISKS OF CANULA BREAKAGE DURING USE (HAZARDOUS SITUATION) AND NEEDLE EMBEDDED (WITH SURGERY NEEDED TO REMOVE - PATIENT HARM) ARE COVERED. HOWEVER, WITHOUT SUFFICIENT INFORMATION REGARDING THE INCIDENT, NO EXACT RISK CAN BE IDENTIFIED. THIS IS THE FIRST COMPLAINT FOR THE CLAIMED BATCH F10663AA REGARDING THE TOTAL QUANTITY SOLD ((B)(4) NEEDLES). THE OCCURRENCE IS EVALUATED AS LOW. BASED ON THE PERFORMED INVESTIGATION, THE RESIDUAL RISK IS EVALUATED AS ACCEPTABLE. FOLLOWING THE PERFORMED INVESTIGATION, NO SPECIFIC ROOT CAUSE HAS BEEN IDENTIFIED. DURING MANUFACTURING PROCESS, THE IN-PROCESS CONTROL RESULTS WERE WITHIN SPECIFICATIONS AND THE USED RAW MATERIALS COMPONENTS WERE RECEIVED WITH A CERTIFICATE OF CONFORMITY FROM SUPPLIER WHICH ATTEST TO THEIR CONFORMITY. SINCE THE ROOT CAUSE IS UNDETERMINED AND THE OCCURRENCE OF THE REPORTED ISSUE IS LOW, NO SPECIFIC CORRECTIVE ACTION WILL BE IMPLEMENTED. NO QUALITY DEFECT FOUND. NO ROOT CAUSE IDENTIFIED (USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED). NO CAPA IMPLEMENTED. WITHOUT FURTHER INFORMATION, NO EXACT RISK CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    SPONTANEOUS REPORT FROM THE UNITED STATES. LOCAL REFERENCE: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES # (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 10-SEP-2024 FROM DENTIST BY EMAIL. THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH SUSPECTED DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT IN AN UNSPECIFIED PATIENT OF UNSPECIFIED AGE, SEX, AND MEDICAL HISTORY DURING AN UNSPECIFIED PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE PATIENT. ON (B)(6) 2024, THE NEEDLE BROKE OFF AT THE HUB AND THE PATIENT HAD TO HAVE SURGERY TO REMOVE IT. THE DOCTOR HAD FOLLOWED UP WITH PATIENT. OTHER INFORMATION OF PRODUCT: BATCH: #F10663AA, EXPIRY DATE: UNKNOWN. THIS CASE WAS CONSIDERED AS SERIOUS AS IT RETRIEVED THE FOLLOWING SERIOUSNESS CRITERIA: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH SUSPECTED DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT IN AN UNSPECIFIED PATIENT OF UNSPECIFIED AGE, SEX, AND MEDICAL HISTORY DURING AN UNSPECIFIED PROCEDURE. THE NEEDLE BROKE OFF AT THE HUB AND THE PATIENT HAD TO HAVE SURGERY TO REMOVE IT. THE DOCTOR HAD FOLLOWED UP WITH PATIENT. PENDING QIR AND FURTHER INFORMATION, NO ROOT CAUSE CAN BE CONCLUDED. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.

    Description of Event or Problem · 0

    SPONTANEOUS REPORT FROM THE UNITED STATES. LOCAL REFERENCE: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES #(B)(4). THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH SUSPECTED DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT IN AN UNSPECIFIED PATIENT OF UNSPECIFIED AGE, SEX, AND MEDICAL HISTORY DURING AN UNSPECIFIED PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE PATIENT. ON (B)(6) 2024, THE NEEDLE BROKE OFF AT THE HUB AND THE PATIENT HAD TO HAVE SURGERY TO REMOVE IT. THE DOCTOR HAD FOLLOWED UP WITH PATIENT. OTHER INFORMATION OF PRODUCT: BATCH: #F10663AA, EXPIRY DATE: UU-AUG-2026. THIS CASE WAS CONSIDERED AS SERIOUS AS IT RETRIEVED THE FOLLOWING SERIOUSNESS CRITERIA: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). FUP #1: RECEIVED QIR. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH SUSPECTED DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT IN AN UNSPECIFIED PATIENT OF UNSPECIFIED AGE, SEX, AND MEDICAL HISTORY DURING AN UNSPECIFIED PROCEDURE. THE NEEDLE BROKE OFF AT THE HUB AND THE PATIENT HAD TO HAVE SURGERY TO REMOVE IT. THE DOCTOR HAD FOLLOWED UP WITH PATIENT. PENDING QIR AND FURTHER INFORMATION, NO ROOT CAUSE CAN BE CONCLUDED. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED. MANUFACTURER'S FINAL COMMENTS: THE CLAIMED DEFECTIVE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND THE BATCH RECORDS AND TRACEABILITY DIDN'T SHOW ANY DEVIATION OR EVENT THAT COULD BE RELATED OR HAVE IMPACT ON THE REPORTED ISSUE. QUALITY DEFECT IS THEREFORE EXCLUDED. MANY FACTORS COULD LEAD TO THE REPORTED ISSUE CANNULA BREAKAGE, SUCH AS: - HIGH PRESSURE DURING INJECTION. - CONSTRAINT ON THE CANNULA DURING INJECTION. - UNEXPECTED MOVEMENT DURING INJECTION. - USE OF SEVERAL CARTRIDGES WITH THE SAME NEEDLE (MULTIPLE NEEDLE USE). - BENDING OR STRESSING OF THE CANNULA. - USE OF NEEDLE NOT RECOMMENDED ACCORDING TO THE INJECTION TYPE. - INJECTION ON A HARD SURFACE. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. IN THE RISK TABLE AR028.01, RISKS OF CANULA BREAKAGE DURING USE (HAZARDOUS SITUATION) AND NEEDLE EMBEDDED (WITH SURGERY NEEDED TO REMOVE - PATIENT HARM) ARE COVERED. HOWEVER, WITHOUT SUFFICIENT INFORMATION REGARDING THE INCIDENT, NO EXACT RISK CAN BE IDENTIFIED. THIS IS THE FIRST COMPLAINT FOR THE CLAIMED BATCH F10663AA REGARDING THE TOTAL QUANTITY SOLD ((B)(4) NEEDLES). THE OCCURRENCE IS EVALUATED AS LOW. BASED ON THE PERFORMED INVESTIGATION, THE RESIDUAL RISK IS EVALUATED AS ACCEPTABLE. FOLLOWING THE PERFORMED INVESTIGATION, NO SPECIFIC ROOT CAUSE HAS BEEN IDENTIFIED. DURING MANUFACTURING PROCESS, THE IN-PROCESS CONTROL RESULTS WERE WITHIN SPECIFICATIONS AND THE USED RAW MATERIALS COMPONENTS WERE RECEIVED WITH A CERTIFICATE OF CONFORMITY FROM SUPPLIER WHICH ATTEST TO THEIR CONFORMITY. SINCE THE ROOT CAUSE IS UNDETERMINED AND THE OCCURRENCE OF THE REPORTED ISSUE IS LOW, NO SPECIFIC CORRECTIVE ACTION WILL BE IMPLEMENTED. NO QUALITY DEFECT FOUND. NO ROOT CAUSE IDENTIFIED (USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED). NO CAPA IMPLEMENTED. WITHOUT FURTHER INFORMATION, NO EXACT RISK CAN BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157965 DARBY PLASTIC HUB NEEDLE 30GA SHORT NEEDLE, DENTAL DZM SOFIC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention