BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN PREMIUM NEEDLES 27GA LONG

    MDR report key: 11289940 · Received February 5, 2021

    Report

    Report Number
    3002987375-2021-00002
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    December 29, 2020
    Report Date
    April 12, 2021
    Manufacturer
    SOFIC SAS
    Product Code
    DZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S DEVICE ANALYSIS RESULTS: THE CONTROLS DURING PRODUCTION MAKE IT POSSIBLE TO CHECK THE QUALITY AND CONFORMITY OF THE THREAD. THE CONTROLS PERFORMED DURING INJECTION ON CALIBER AND DURING ASSEMBLY ON SYRINGES. NO NON-COMPLIANCE AND / OR DEVIATION RELATED TO A SCREWING OR HOLD DEFECT IN THIS NEEDLE BATCHES WAS RECORDED DURING THE PRODUCTION. THIS IS THE FIRST COMPLAINT ON THESE BATCHES FOR SCREWING / THREAD TOO LOOSE DEFECT. THE PRACTITIONER DID NOT SEND INCRIMINATED NEEDLES BUT RETURNED NEEDLES FROM THE SAME BATCHES. SOFIC PERFORMED TEST ON NEEDLES FROM RETENTION BOX WITH 20 SYRINGES COMPLIANT TO ISO9997. NO DEVIATION WAS OBSERVED DURING THESE TESTS. REGARDING THE DESCRIPTION OF THE DEFECT AND THE RESULTS TO THE TESTS PERFORMED DURING INVESTIGATION, THE CAUSE OF THE DEFECT CANNOT BE PROVEN. CONSEQUENTLY, AND WITHOUT ANY DEFECT OBSERVED DURING THIS INVESTIGATION, USE OF A NON-COMPLIANT SYRINGE TO THE ISO9997 OR WITH A POOR THREAD IS PRIVILEGED. REMEDIAL ACTION / CORRECTIVE / PREVENTIVE / FIELD SAFETY CORRECTIVE ACTION: NO OTHER INCIDENTS HAVE BEEN REGISTERED ON THE BATCH, NO SIMILAR INCIDENT WERE RECEIVED IN THE GLOBAL SAFETY DATABASE, SO NO CAPA IS REQUIRED. FINAL COMMENTS FROM THE MANUFACTURER: THE ROOT CAUSES TO CONSIDER ARE PRODUCTS QUALITY DEFECT OR PRODUCT MISHANDLING WHILE SCREWING THE NEEDLE IN THE SYRINGE. NO PRODUCT DEFECT WAS RETRIEVED BY QUALITY INVESTIGATIONS BUT THERE WAS NO INFORMATION TO IDENTIFY A MISUSE OR INAPPROPRIATE USAGE DURING THE LOCAL INJECTION. NO ROOT CAUSE COULD BE DEFINED BUT THE USE OF A NON-COMPLIANT SYRINGE WAS PRIVILEGED. FURTHER INVESTIGATIONS ALL THE NEEDLES TESTED ON SYRINGE CONFORM TO THE ISO9997 ARE CONFORM TO THE SPECIFICATION FIXED BY ISO7885 (>22N). CONSEQUENTLY, NO NEEDLE DEFECT WAS PROVEN FOR THESE NEEDLES BATCHES. PRODUCTION: CONSEQUENTLY, THIS CAUSE CAN BE RULED OUT. THIS CONCLUSION IS CORROBORATED BY THE RESULTS OBSERVED DURING THE PRESENT INVESTIGATION. PRACTITIONER: CONSEQUENTLY, AND WITHOUT ANY DEFECT OBSERVED DURING THIS INVESTIGATION, USE OF A NON-COMPLIANT SYRINGE TO THE ISO9997 OR WITH A POOR THREAD IS PRIVILEGED. WORKFORCE: THE WORKFORCE CAUSE DUE TO OPERATORS IN CHARGE DURING THE PRODUCTION OF THIS BATCH CAN BE EXCLUDED. EQUIPMENT: THE EQUIPMENT CAUSE DUE TO DEFICIENCY DURING THE PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 0

    SPONTANEOUS REPORT, FROM UNITED STATES LOCAL REFERENCE: (B)(4), DEALER REFERENCE NUMBERS: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES (B)(4). IINITIAL INFORMATION RECEIVED ON 29-DEC-2020 FROM DENTIST BY DEALER HENRY SCHEIN, AND FORWARDED TO SEPTODONT ON 01-JAN-2021, HOWEVER THE CRITERIA FOR AN ICSR WAS NOT MET AS NO ADVERSE EVENT WAS REPORTED AT THIS TIME. FOLLOW-UP #1 INFORMATION WAS RECEIVED ON 15-JAN-2021 FROM DENTIST BY SEPTODONT IN WHICH AN INCIDENT INVOLVING A PATIENT WAS REPORTED, WHICH IS CONSIDERED DAY 0 FOR THIS CASE. FOLLOW-UP #2 INFORMATION WAS RECEIVED ON 15-MAR-2021 FROM QUALITY INVESTIGATION PERFORMED BY MANUFACTURER. INITIAL AND FOLLOW-UP INFORMATION ARE INTEGRATED INTO THE NARRATIVE BELOW: COURSE OF EVENTS: THIS CASE CONCERNES A PATIENT OF UNSPECIFIED AGE, GENDER AND MEDICAL HISTORY. ON 29-DEC-2020, THE PATIENT WAS UNDERGOING AN UNSPECIFIED DENTAL PROCEDURE INVOLVING ONE OF THE FOLLOWING SUSPECT DEVICES: HENRY SCHEIN PREMIUM NEEDLE 27GA LONG (BATCH NUMBER: F08708AA, EXPIRY DATE 20-JUN-2024), OR HENRY SCHEIN PREMIUM NEEDLE 30GA SHORT (BATCH NUMBER: F09305AA, EXPIRY DATE: 20-DEC-2024). THE REPORTER NOTED THAT THE NEEDLES DIDN'T FIT THE SYRINGES AND THEY WERE TOO LOOSE. WHEN THE NEEDLES WERE PUT ON THE SYRINGE, THEY WOULD NOT GRIP THE SYRINGE PROPERLY AND WOULD POP OFF THE END OF THE SYRINGE. THIS HAPPENED ONE TIME WHILE THE DRUG WAS BEING ADMINISTERED TO THE PATIENT. THE OFFICE HAS NEVER HAD THIS ISSUE BEFORE. OUTCOME: THE DOCTOR WAS ABLE TO RETRIEVE THE NEEDLE SAFELY FROM THE PATIENT'S MOUTH. A QUALITY INVESTIGATION WAS PERFORMED BY THE MANUFACTURER: THE PRACTITIONER DID NOT SEND INCRIMINATED NEEDLES BUT RETURNED NEEDLES FROM THE SAME BATCHES. SOFIC PERFORMED TEST ON NEEDLES FROM RETENTION BOX WITH 20 SYRINGES COMPLIANT TO ISO9997. NO DEVIATION WAS OBSERVED DURING THESE TESTS. REGARDING THE DESCRIPTION OF THE DEFECT AND THE RESULTS TO THE TESTS PERFORMED DURING INVESTIGATION, THE CAUSE OF THE DEFECT CANNOT BE PROVEN. CONSEQUENTLY, AND WITHOUT ANY DEFECT OBSERVED DURING THIS INVESTIGATION, USE OF A NON-COMPLIANT SYRINGE TO THE ISO9997 OR WITH A POOR THREAD IS PRIVILEGED. NO FURTHER INFORMATION IS EXPECTED. ===================================== FOLLOW-UP #2 RECEIVED ON 15-MAR-2021: QUALITY INVESTIGATION FROM MANUFACTURER. ===================================== CAUSALITY REASSESSED ON 22-MAR-2021 BY AL ON FOLLOW-UP INFORMATION RECEIVED ON 15-MAR-2021: A. SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)). B. LISTEDNESS/EXPECTEDNESS: FOR PREMIUM NEEDLES 27GA LONG FOREIGN BODY IN GASTROINTESTINAL TRACT: UNLISTED EU AND UNEXPECTED US/CA; NEEDLE ISSUE: UNLISTED EU AND UNEXPECTED US/CA; FOR PREMIUM NEEDLES 30GA SHORT; FOREIGN BODY IN GASTROINTESTINAL TRACT: UNLISTED EU AND UNEXPECTED US/CA; NEEDLE ISSUE: UNLISTED EU AND UNEXPECTED US/CA; C. CAUSALITY; A) LATENCY - COMPATIBLE; B) RECOGNIZED ASSOCIATION - NO; C) ANALYSIS - THE NEEDLES DID NOT FIT IN THE SYRINGE AND POPPED OFF IN PATIENT MOUTHS. THE ROOT CAUSES TO CONSIDER ARE PRODUCTS QUALITY DEFECT OR PRODUCT MISHANDLING WHILE SCREWING THE NEEDLE IN THE SYRINGE. NO PRODUCT DEFECT WAS IDENTIFIED BY QUALITY INVESTIGATIONS BUT THERE WAS NO INFORMATION ABOUT A MISUSE OR INAPPROPRIATE USAGE DURING THE LOCAL INJECTION. NO ROOT CAUSE COULD BE DEFINED BUT THE USE OF A NON-COMPLIANT SYRINGE WAS PRIVILEGED. NO OTHER INCIDENTS HAVE BEEN REGISTERED ON THE BATCH, NO SIMILAR INCIDENT WERE RECEIVED IN THE GLOBAL SAFETY DATABASE, SO NO CAPA IS REQUIRED. D) DECHALLENGE - N/A; E) RECHALLENGE - N/A; CONCLUDED CAUSALITY WHO: UNLIKELY. FOLLOW-UP INFORMATION RECEIVED ON 15-MAR-2021: ASSESSMENT CHANGED FROM NOT ASSESSABLE TO UNLIKELY FOLLOWING QUALITY INVESTIGATIONS RESULTS.

    Additional Manufacturer Narrative · 1

    AT THIS STAGE, AWAITING THE QUALITY INVESTIGATION, QUALITY DEFECT COULD NOT BE RULED OUT. THE OTHER CAUSE IS UNPROPER PRODUCT USE (MISHANDLING) OR PATIENT MOVEMENT DURING INJECTION EVEN THOUGH NO INFORMATION IN FAVOR OF IT IS PROVIDED. NO CAPA AT THIS STAGE: INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    SPONTANEOUS REPORT, FROM UNITED STATES LOCAL REFERENCE: (B)(4), DEALER REFERENCE NUMBERS: (B)(4) AND (B)(4) . QUALITY COMPLAINT WAS OPENED: REFERENCES (B)(4) . INITIAL INFORMATION RECEIVED ON 29-DEC-2020 FROM DENTIST BY DEALER HENRY SCHEIN, AND FORWARDED TO SEPTODONT ON 01-JAN-2021, HOWEVER THE CRITERIA FOR AN ICSR WAS NOT MET AS NO ADVERSE EVENT WAS REPORTED AT THIS TIME. FUP INFORMATION WAS RECEIVED ON 15-JAN-2021 FROM DENTIST BY SEPTODONT IN WHICH AN INCIDENT INVOLVING A PATIENT WAS REPORTED, WHICH IS CONSIDERED DAY 0 FOR THIS CASE. INITIAL AND FOLLOW UP INFORMATION ARE INTEGRATED INTO THE NARRATIVE BELOW: COURSE OF EVENTS: THIS CASE CONCERNES A PATIENT OF UNSPECIFIED AGE, GENDER AND MEDICAL HISTORY. ON (B)(6) 2020, THE PATIENT WAS UNDERGOING AN UNSPECIFIED DENTAL PROCEDURE INVOLVING ONE OF THE FOLLOWING SUSPECT DEVICES: HENRY SCHEIN PREMIUM NEEDLE 27GA LONG (BATCH NUMBER: F08708AA, EXPIRY DATE 20-JUN-2024), OR HENRY SCHEIN PREMIUM NEEDLE 30GA SHORT (BATCH NUMBER: F09305AA, EXPIRY DATE: 20-DEC-2024). THE REPORTER NOTED THAT THE NEEDLES DIDN'T FIT THE SYRINGES AND THEY WERE TOO LOOSE. WHEN THE NEEDLES WERE PUT ON THE SYRINGE, THEY WOULD NOT GRIP THE SYRINGE PROPERLY AND WOULD POP OFF THE END OF THE SYRINGE. THIS HAPPENED ONE TIME WHILE THE DRUG WAS BEING ADMINISTERED TO THE PATIENT. THE OFFICE HAS NEVER HAD THIS ISSUE BEFORE. OUTCOME: THE DOCTOR WAS ABLE TO RETRIEVE THE NEEDLE SAFELY FROM THE PATIENT'S MOUTH. QUALITY INVESTIGATION RESULTS ARE PENDING. FOLLOW-UP #1 RECEIVED ON 15-JAN-2021: PROVIDED INFORMATION ON AN ADVERSE EVENT INVOLVING A PATIENT. CAUSALITY ASSESSMENT ON (B)(6) 2021, ON INITIAL INFORMATION RECEIVED ON 15-JAN-2021: SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)). LISTEDNESS/EXPECTEDNESS: FOR PREMIUM NEEDLES 27GA LONG, FOREIGN BODY IN GASTROINTESTINAL TRACT: UNLISTED EU AND UNEXPECTED US/(B)(6), NEEDLE ISSUE: UNLISTED EU AND UNEXPECTED US/(B)(6). FOR PREMIUM NEEDLES 30GA SHORT FOREIGN BODY IN GASTROINTESTINAL TRACT: UNLISTED EU AND UNEXPECTED US/(B)(6), NEEDLE ISSUE: UNLISTED EU AND UNEXPECTED US/(B)(6). CAUSALITY LATENCY - COMPATIBLE, RECOGNIZED ASSOCIATION - NO, ANALYSIS - THE NEEDLES DID NOT FIT IN THE SYRINGE AND POPPED OFF IN PATIENT MOUTHS. BASED ON THE PROVIDE BATCHES, NO SIMILAR ISSUE WERE RECEIVED AND NO INCREASE OF SIMILAR INCIDENT IS NOTED. THE ROOT CAUSES TO CONSIDER ARE PRODUCTS QUALITY DEFECT OR PRODUCT MISHANDLING WHILE SCREWING THE NEEDLE IN THE SYRINGE. BUT THE ISSUES WAS FACED USING TWO DIFFERENT BATCHES AND TWO PRODUCT (NEEDLE OF 27GA AND 30GA), WITCH MAKE QUALITY DEFECT LESS PROBABLE BUT, HOWEVER, NOT RULED OUT AWAITING QUALITY INVESTIGATION RESULT. NO CAPA AT THIS STAGE. DECHALLENGE - N/A, RECHALLENGE - N/A. CONCLUDED CAUSALITY WHO: POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185897 HENRY SCHEIN PREMIUM NEEDLES 27GA LONG HENRY SCHEIN PREMIUM DENTAL NEEDLE DZM SOFIC SAS F08708AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention