BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN PREMIUM 27GA LONG

    MDR report key: 16707506 · Received April 10, 2023

    Report

    Report Number
    9610964-2023-00002
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    March 23, 2023
    Report Date
    June 26, 2023
    Manufacturer
    SOFIC
    Product Code
    DZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S FINAL COMMENTS: THE INCRIMINATED DEFECTIVE SAMPLES WEREN'T SENT BACK FOR ANALYSIS, A NON-USED SAMPLES FROM THE SAME BATCH WERE RETURNED FOR INVESTIGATION. TWO TYPES OF TEST WERE CARRIED OUT : HOLDING BETWEEN CAP AND HUB BEFORE USE; FUNCTIONAL TESTING. FOLLOWING THE PERFORMED INVESTIGATIONS, NO QUALITY DEFECT HAS BEEN NOTICED ON THE TESTED SAMPLES THAT COULD LEAD TO THE CLAIMED DEFECTS, THE PRODUCTS DESIGN PERFORMANCE REMAINS WITHIN SPECIFICATIONS. IT APPEARS THAT THIS INCIDENT OF NEEDLE STICK HAS OCCURRED SINCE THE CHANGE FROM THE OPAQUE/WHITE NEEDLE HUBS TO THE NEW TRANSPARENT NEEDLE HUBS. THIS CHANGE WAS MADE IN LINE WITH THE CHANGE OF THE NEEDLE ASSEMBLY GLUE (FROM HEAT CURED TO UV LIGHT CURED) AND WAS A PROCESS IMPROVEMENT TO IMPLEMENT AN ONLINE CANULA TRACTION TEST FOR 100% OF THE NEEDLES. THE IDENTIFIED ROOT CAUSE IS THAT THE TRANSPARENT POLYPROPYLENE RETRACTS MORE WHICH CAN SOMETIMES RESULT TO A LOWER HOLDING STRENGTH OF CAPS ON HUBS. THEREFORE, THE INCIDENT IS A CONSEQUENCE OF THE NEEDLE UNCAPPING INCIDENT DURING DEVICES USE. USE ERROR IS ALSO TO CONSIDER. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION (FSCA): BASED ON THE COMPLAINTS, THE MANUFACTURER WILL MAKE A MODIFICATION OF THE PROCESS - A CHANGE IN POLYPROPYLENE RESIN - WHICH SHOULD ADDRESS THE SMALL CHANGE BACK TO THE WAY IT WAS PREVIOUSLY. NO QUALITY DEFECT IDENTIFIED ON THE TESTED SAMPLES FROM THE SAME BATCH. ROOT CAUSE IDENTIFIED IS THE COMPONENT CHANGE OF THE HUB. A CHANGE IN PROPYLENE RESIN IS CONCLUDED. USE ERROR IS TO CONSIDER.

    Description of Event or Problem · 0

    SPONTANEOUS REPORT, FROM CANADA LOCAL REFERENCE #: (B)(4) QUALITY COMPLAINT WAS OPENED: REFERENCE #: (B)(4) THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 29-MAR-2023 FROM DENTIST BY DEALER AND FORWARDED TO SEPTODONT ON 30-MAR-2023 VIA EMAIL. FOLLOW-UP #1 WAS RECEIVED ON 29-MAY-2023 FROM THE DENTIST VIA EMAIL. FOLLOW-UP #2 WAS RECEIVED ON 13-JUN-2023 FROM THE QUALITY DEPARTMENT BY EMAIL. ALL THE INFORMATION WAS PROCESSED TOGETHER. DESCRIPTION OF THE INCIDENT (NARRATIVE): THIS CASE DESCRIBED ACCIDENTAL NEEDLE STICK, DEVICE CONNECTION FIT ISSUE, AND NEEDLE COVER DEFECT WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA LONG NEEDLE IN A FEMALE DENTAL ASSISTANT WITH AN UNSPECIFIED MEDICAL HISTORY. ON (B)(6) 2023, THE DENTAL ASSISTANT WAS POKED BY THE DIRTY USED SUSPECT PRODUCT AND SHE SQUEEZED OUT SOME BLOOD. THE DENTAL ASSISTANT WENT TO THE HOSPITAL TO GET BLOODWORK DONE ON THE SAME DAY. THE RESULTS ARE EXPECTED IN ABOUT 3 MONTHS. IT WAS ALSO REPORTED THAT THE NEEDLE DID NOT FIT IN THE SYRINGE AND THE CAP CAME OFF. NO INFORMATION REGARDING CORRECTIVE ACTION WAS PROVIDED. INFORMATION ON THE BATCH: #F11163AA, EXPIRY DATE: 31-JAN-2027. THE DENTAL ASSISTANT WILL HAVE ANOTHER BLOODWORK IN A FEW MONTHS. AT THE TIME OF THIS REPORT, THE OUTCOME WAS UNKNOWN. THIS CASE WAS CONSIDERED SERIOUS BY THE COMPANY WITH SERIOUSNESS CRITERIA "OTHER MEDICALLY IMPORTANT CONDITION" FOR PT "HEMORRHAGE" AND "EXPOSURE TO CONTAMINATED DEVICE" AS THEY ARE INCLUDED IN THE IME LIST AND PER DATA ENTRY CONVENTION AS THE ASSISTANT HAD BLOODWORK DONE. ----------------------- FOLLOW-UP#1: RECEIVED ADDITIONAL INFORMATION. FOLLOW-UP#2: QIR RECEIVED FROM THE QUALITY DEPARTMENT. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED ACCIDENTAL NEEDLE STICK WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA LONG NEEDLE IN A FEMALE DENTAL ASSISTANT. THE DENTAL ASSISTANT WAS POKED BY THE SUSPECT PRODUCT AND SHE SQUEEZED OUT SOME BLOOD. THE DENTAL ASSISTANT WENT TO THE HOSPITAL TO GET BLOODWORK DONE. THE RESULTS ARE EXPECTED IN ABOUT 3 MONTHS. IT WAS ALSO REPORTED THAT THE NEEDLE DID NOT FIT IN THE SYRINGE. THIS INCIDENT CAN BE DUE TO A WRONG WAY OF RECAPPING THE NEEDLE OR A DEFECT OF THE PROTECTIVE CAP. HOWEVER, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, THE MAIN ROOT CAUSE CANNOT BE DETERMINED AND MISUSE CANNOT BE EXCLUDED. FROM PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION RESULTS AND/OR ADDITIONAL INFORMATION, AND WITHOUT ANTERIORITY OF THE BATCH, NO CAPA IS REQUIRED.

    Description of Event or Problem · 0

    SPONTANEOUS REPORT, FROM US LOCAL REFERENCE #: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCE #: (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 29-MAR-2023 FROM DENTIST BY DEALER AND FORWARDED TO SEPTODONT ON 30-MAR-2023 VIA EMAIL. DESCRIPTION OF THE INCIDENT (NARRATIVE): THIS CASE DESCRIBED ACCIDENTAL NEEDLE STICK WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA LONG NEEDLE IN A FEMALE DENTAL ASSISTANT WITH AN UNSPECIFIED MEDICAL HISTORY. ON (B)(6) 2023, THE DENTAL ASSISTANT WAS POKED BY THE SUSPECT PRODUCT AND SHE SQUEEZED OUT SOME BLOOD. THE DENTAL ASSISTANT WENT TO THE HOSPITAL TO GET BLOODWORK DONE. THE RESULTS ARE EXPECTED IN ABOUT 3 MONTHS. IT WAS ALSO REPORTED THAT THE NEEDLE DID NOT FIT IN THE SYRINGE. NO ACTION REGARDING CORRECTIVE ACTION WAS PROVIDED. INFORMATION ON THE BATCH: #F11163AA, EXPIRY DATE: 31-JAN-2027. AT THE TIME OF THIS REPORT, THE OUTCOME WAS UNKNOWN. THIS CASE WAS CONSIDERED SERIOUS BY THE COMPANY WITH SERIOUSNESS CRITERIA "OTHER MEDICALLY IMPORTANT CONDITION" FOR PT "HEMORRHAGE" AS IT IS INCLUDED IN THE IME LIST AND PER DATA ENTRY CONVENTION AS THE ASSISTANT HAD BLOODWORK DONE. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED ACCIDENTAL NEEDLE STICK WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA LONG NEEDLE IN A FEMALE DENTAL ASSISTANT. THE DENTAL ASSISTANT WAS POKED BY THE SUSPECT PRODUCT AND SHE SQUEEZED OUT SOME BLOOD. THE DENTAL ASSISTANT WENT TO THE HOSPITAL TO GET BLOODWORK DONE. THE RESULTS ARE EXPECTED IN ABOUT 3 MONTHS. IT WAS ALSO REPORTED THAT THE NEEDLE DID NOT FIT IN THE SYRINGE. THIS INCIDENT CAN BE DUE TO A WRONG WAY OF RECAPPING THE NEEDLE OR A DEFECT OF THE PROTECTIVE CAP. HOWEVER, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, THE MAIN ROOT CAUSE CANNOT BE DETERMINED AND MISUSE CANNOT BE EXCLUDED.

    Description of Event or Problem · 0

    SPONTANEOUS REPORT, FROM CA LOCAL REFERENCE #: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCE #: (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 29-MAR-2023 FROM DENTIST BY DEALER AND FORWARDED TO SEPTODONT ON 30-MAR-2023 VIA EMAIL. FOLLOW-UP #1 WAS RECEIVED ON 29-MAY-2023 FROM THE DENTIST VIA EMAIL. ALL THE INFORMATION WAS PROCESSED TOGETHER. DESCRIPTION OF THE INCIDENT (NARRATIVE): THIS CASE DESCRIBED ACCIDENTAL NEEDLE STICK , DEVICE CONNECTION FIT ISSUE, AND NEEDLE COVER DEFECT WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA LONG NEEDLE IN A FEMALE DENTAL ASSISTANT WITH AN UNSPECIFIED MEDICAL HISTORY. ON (B)(6) 2023, THE DENTAL ASSISTANT WAS POKED BY THE DIRTY USED SUSPECT PRODUCT AND SHE SQUEEZED OUT SOME BLOOD. THE DENTAL ASSISTANT WENT TO THE HOSPITAL TO GET BLOODWORK DONE ON THE SAME DAY. THE RESULTS ARE EXPECTED IN ABOUT 3 MONTHS. IT WAS ALSO REPORTED THAT THE NEEDLE DID NOT FIT IN THE SYRINGE AND THE CAP CAME OFF. NO INFORMATION REGARDING CORRECTIVE ACTION WAS PROVIDED. INFORMATION ON THE BATCH: #F11163AA, EXPIRY DATE: 31-JAN-2027. THE DENTAL ASSISTANT WILL HAVE ANOTHER BLOODWORK IN A FEW MONTHS. AT THE TIME OF THIS REPORT, THE OUTCOME WAS UNKNOWN. THIS CASE WAS CONSIDERED SERIOUS BY THE COMPANY WITH SERIOUSNESS CRITERIA "OTHER MEDICALLY IMPORTANT CONDITION" FOR PT "HEMORRHAGE" AND "EXPOSURE TO CONTAMINATED DEVICE" AS THEY ARE INCLUDED IN THE IME LIST AND PER DATA ENTRY CONVENTION AS THE ASSISTANT HAD BLOODWORK DONE. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED ACCIDENTAL NEEDLE STICK WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA LONG NEEDLE IN A FEMALE DENTAL ASSISTANT. THE DENTAL ASSISTANT WAS POKED BY THE SUSPECT PRODUCT AND SHE SQUEEZED OUT SOME BLOOD. THE DENTAL ASSISTANT WENT TO THE HOSPITAL TO GET BLOODWORK DONE. THE RESULTS ARE EXPECTED IN ABOUT 3 MONTHS. IT WAS ALSO REPORTED THAT THE NEEDLE DID NOT FIT IN THE SYRINGE. THIS INCIDENT CAN BE DUE TO A WRONG WAY OF RECAPPING THE NEEDLE OR A DEFECT OF THE PROTECTIVE CAP. HOWEVER, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, THE MAIN ROOT CAUSE CANNOT BE DETERMINED AND MISUSE CANNOT BE EXCLUDED. FROM PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION RESULTS AND/OR ADDITIONAL INFORMATION, AND WITHOUT ANTERIORITY OF THE BATCH, NO CAPA IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794465 HENRY SCHEIN PREMIUM 27GA LONG DENTAL NEEDLE, SINGLE-USE DZM SOFIC F11163AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other