HENRY SCHEIN PREMIUM NEEDLES 27GA SHORT
Report
- Report Number
- 3008242564-2023-00001
- Event Type
- Injury
- Date Received
- July 19, 2023
- Date of Event
- March 31, 2023
- Report Date
- September 6, 2023
- Manufacturer
- SOFIC
- Product Code
- DZM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
DESCRIPTION OF THE MANUFACTURER'S EVALUATION CONCERNING POSSIBLE ROOT CAUSES/CAUSATIVE FACTORS AND CONCLUSION: THE TESTS WERE PERFORMED ON SOFIC RETENTION SAMPLES FOR INVESTIGATION. 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. REGARDING THE DEFECT HOLDING ISSUE BETWEEN CAP AND HUB, FOR BETTER USE, DURING REMOVING WE RECOMMEND USER TO UNSCREW WITHOUT CARTRIDGE INSIDE SYRINGE. CONCERNING THE NEEDLE STICK INCIDENT, IT COULD BE A CONSEQUENCE OF THE NEEDLE UNCAPPING DURING DEVICES USE. IT APPEARS THAT IT 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. USE ERROR/ABNORMAL USE IS EXCLUDED. FINAL COMMENTS FROM THE MANUFACTURER: NO QUALITY DEFECT ROOT CAUSE: CHANGE FROM THE OPAQUE/WHITE NEEDLE HUBS TO THE NEW TRANSPARENT NEEDLE HUBS TO MAKE 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. USE ERROR/ABNORMAL USE EXCLUDED. CAPA : CHANGE IN PROPYLENE RESIN WHICH SHOULD ADDRESS THE SMALL CHANGE BACK TO THE WAY IT WAS BEFORE. 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.
DESCRIPTION OF THE MANUFACTURER'S EVALUATION CONCERNING POSSIBLE ROOT CAUSES/CAUSATIVE FACTORS AND CONCLUSION: THE TESTS WERE PERFORMED ON SOFIC RETENTION SAMPLES FOR INVESTIGATION. 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. REGARDING THE DEFECT HOLDING ISSUE BETWEEN CAP AND HUB, FOR BETTER USE, DURING REMOVING WE RECOMMEND USER TO UNSCREW WITHOUT CARTRIDGE INSIDE SYRINGE. CONCERNING THE NEEDLE STICK INCIDENT, IT COULD BE A CONSEQUENCE OF THE NEEDLE UNCAPPING DURING DEVICES USE. IT APPEARS THAT IT 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. USE ERROR/ABNORMAL USE IS EXCLUDED. FINAL COMMENTS FROM THE MANUFACTURER: NO QUALITY DEFECT. ROOT CAUSE: CHANGE FROM THE OPAQUE/WHITE NEEDLE HUBS TO THE NEW TRANSPARENT NEEDLE HUBS TO MAKE 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. USE ERROR/ABNORMAL USE EXCLUDED. CAPA : CHANGE IN PROPYLENE RESIN WHICH SHOULD ADDRESS THE SMALL CHANGE BACK TO THE WAY IT WAS BEFORE. 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.
SPONTANEOUS REPORT, FROM THE UNITED STATES. LOCAL REFERENCE: #(B)(4). QUALITY REFERENCE WAS OPENED: NARA.2023.189. LINKED CASE 2 OF 2: (B)(4). (SAME PRODUCT AND BATCH, SIMILAR REACTION, SAME REPORTER, AND DIFFERENT PATIENTS). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE DENTIST BY THE DEALER AND FORWARDED TO SEPTODONT ON (B)(6) 2023 VIA EMAIL. DESCRIPTION OF THE INCIDENT (NARRATIVE): THE REPORT DESCRIBED EXPOSURE TO CONTAMINATED DEVICE, ACCIDENTAL NEEDLE STICK AND NEEDLE COVER DEFECT WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA SHORT NEEDLE IN A DENTAL OFFICE EMPLOYEE. THE INCIDENT OCCURRED IN A FEMALE DENTAL OFFICE EMPLOYEE OF UNKNOWN AGE AND WITH AN UNSPECIFIED MEDICAL HISTORY. ON (B)(6) 2023, THE DENTAL EMPLOYEE WAS PUTTING AWAY THE TRAY AND THE INSTRUMENTS AFTER A RESTORATIVE PROCEDURE. THE SYRINGE STARTED ROLLING OFF THE TRAY AND SHE TRIED TO CATCH IT, BUT THE CAP CAME OFF AND SHE WAS STRUCK BY THE NEEDLE THROUGH THE GLOVE AS SHE GRABBED IT. OTHER INFORMATION OF PRODUCT: BATCH: #F10725AA, EXPIRY DATE: 31-AUG-2026. CORRECTIVE TREATMENT: THE EMPLOYEE WAS SENT TO EVERETT CLINIC FOR EVALUATION. BLOOD WORK WAS ALSO PERFORMED. ONE OF THE TWO EMPLOYEES ALSO HAD A FOLLOW-UP BLOOD WORK AND WAS ADMINISTERED HEPATITIS VACCINE. THIS CASE WAS CONSIDERED SERIOUS BY THE COMPANY WITH SERIOUSNESS CRITERIA "OTHER MEDICALLY IMPORTANT CONDITION" FOR PT "EXPOSURE TO CONTAMINATED DEVICE". MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED A DETACHMENT OF THE NEEDLE PROTECTIVE CAP LEADING TO ACCIDENTAL NEEDLE STICK. IN THIS CASE, THE CAP CAME OFF AFTER THE DENTAL PROCEDURE WAS PERFORMED IN A CONTEXT OF FALLING SYRINGE, SO IT MAY HAVE BEEN BADLY RECAPPED. HOWEVER, A DETACHMENT OF THE PROTECTIVE CAP COULD BE DUE TO A QUALITY DEFECT OF THE DEVICE SUCH AS INCORRECT DIMENSION OF THE OUTER DIAMETER OF THE CAP. THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, NO ROOT CAUSE COULD BE DETERMINED. A USE ERROR OR ABNORMAL USE WAS NOT EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
SPONTANEOUS REPORT, FROM THE UNITED STATES. LOCAL REFERENCE: #(B)(4). QUALITY REFERENCE WAS OPENED: #(B)(4). DEALER REFERENCE NUMBER: #(B)(4). LINKED CASE 2 OF 2: #(B)(4) (SAME PRODUCT AND BATCH, SIMILAR REACTION, SAME REPORTER, AND DIFFERENT PATIENTS). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 07-JUL-2023 FROM THE DENTIST BY THE DEALER AND FORWARDED TO SEPTODONT ON 10-JUL-2023 VIA EMAIL. FOLLOW-UP #1 RECEIVED ON 28-JUL-2023 FROM THE DENTIST VIA EMAIL. FOLLOW-UP #2 RECEIVED ON 07-AUG-2023 AND FOLLOW-UP #3 RECEIVED ON 30-AUG-2023 FROM QUALITY DEPARTMENT. ALL INFORMATION WERE PROCESSED TOGETHER. DESCRIPTION OF THE INCIDENT (NARRATIVE): THE REPORT DESCRIBED EXPOSURE TO CONTAMINATED DEVICE, ACCIDENTAL NEEDLE STICK AND NEEDLE COVER DEFECT WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA SHORT NEEDLE IN A DENTAL OFFICE EMPLOYEE. THE INCIDENT OCCURRED WITH A 47-YEAR-OLD FEMALE DENTAL ASSISTANT (WEIGHT: 63.5 KG/140 LBS), WHO WAS NOT PREGNANT AT THE TIME OF THE REPORT AND HAD NEVER BEEN ADMINISTERED WITH A SIMILAR PRODUCT IN THE PAST. THE PATIENT HAD A MEDICAL HISTORY OF THYROID DISORDER. ON (B)(6) 2023, THE DENTAL ASSISTANT WAS PUTTING AWAY THE TRAY AND THE INSTRUMENTS AFTER A RESTORATIVE PROCEDURE. THE SYRINGE ROLLED OFF THE TRAY AND SHE TRIED TO CATCH IT, BUT THE CAP CAME OFF AND SHE WAS STRUCK BY THE NEEDLE THROUGH THE GLOVE AS SHE GRABBED IT. SHE PUNCTURED HER FINGER THROUGH THE GLOVE WHEN SHE GRABBED THE SYRINGE. OTHER INFORMATION OF PRODUCT: BATCH: #F10725AA, EXPIRY DATE: 31-AUG-2026. CORRECTIVE TREATMENT: THE DENTAL ASSISTANT HAD 3 VISITS TO CLINICS FOR EXAM, VACCINATION AND BLOOD TESTING, SINCE THE NEEDLE WAS A USED/CONTAMINATED NEEDLE. BLOOD WORK WAS PERFORMED. THE DENTAL ASSISTANT HAD A FOLLOW-UP BLOOD WORK AND WAS ADMINISTERED HEPATITIS VACCINE. THIS CASE WAS CONSIDERED SERIOUS BY THE COMPANY WITH SERIOUSNESS CRITERIA "OTHER MEDICALLY IMPORTANT CONDITION" FOR PT "EXPOSURE TO CONTAMINATED DEVICE". ------------------------------------------------- FOLLOW-UP #1 RECEIVED ON 28-JUL-2023: ADDITIONAL INFORMATION PROVIDED REGARDING THE PATIENT (INITIALS, AGE, DATE OF BIRTH AND MEDICAL HISTORY). FOLLOW-UP #2 RECEIVED ON 07-AUG-2023: ADDITIONAL INFORMATION PROVIDED REGARDING THE QUALITY INVESTIGATION. FOLLOW-UP #3 RECEIVED ON 30-AUG-2023: ADDITIONAL INFORMATION PROVIDED REGARDING THE QUALITY INVESTIGATION. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED A DETACHMENT OF THE NEEDLE PROTECTIVE CAP LEADING TO ACCIDENTAL NEEDLE STICK. IN THIS CASE, THE CAP CAME OFF AFTER THE DENTAL PROCEDURE WAS PERFORMED IN A CONTEXT OF FALLING SYRINGE, SO IT MAY HAVE BEEN BADLY RECAPPED. HOWEVER, A DETACHMENT OF THE PROTECTIVE CAP COULD BE DUE TO A QUALITY DEFECT OF THE DEVICE SUCH AS INCORRECT DIMENSION OF THE OUTER DIAMETER OF THE CAP. THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, NO ROOT CAUSE COULD BE DETERMINED. A USE ERROR OR ABNORMAL USE WAS NOT EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
SPONTANEOUS REPORT, FROM THE UNITED STATES. LOCAL REFERENCE#: (B)(4). LINKED CASE 2 OF 2: #: (B)(4) (SAME PRODUCT AND BATCH, SIMILAR REACTION, SAME REPORTER, AND DIFFERENT PATIENTS). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 07-JUL-2023 FROM THE DENTIST BY THE DEALER AND FORWARDED TO SEPTODONT ON 10-JUL-2023 VIA EMAIL. FOLLOW-UP #1 RECEIVED ON 28-JUL-2023 FROM THE DENTIST VIA EMAIL. FOLLOW-UP #2 RECEIVED ON 07-AUG-2023 FROM QUALITY DEPARTMENT. ALL INFORMATION WERE PROCESSED TOGETHER. DESCRIPTION OF THE INCIDENT (NARRATIVE): THE REPORT DESCRIBED EXPOSURE TO CONTAMINATED DEVICE, ACCIDENTAL NEEDLE STICK AND NEEDLE COVER DEFECT WITH SUSPECTED DEVICE HENRY SCHEIN PREMIUM 27GA SHORT NEEDLE IN A DENTAL OFFICE EMPLOYEE. THE INCIDENT OCCURRED WITH A 47-YEAR-OLD FEMALE DENTAL ASSISTANT (WEIGHT: 63.5 KG/140 LBS), WHO WAS NOT PREGNANT AT THE TIME OF THE REPORT AND HAD NEVER BEEN ADMINISTERED WITH A SIMILAR PRODUCT IN THE PAST. THE PATIENT HAD A MEDICAL HISTORY OF THYROID DISORDER. ON (B)(6) 2023, THE DENTAL ASSISTANT WAS PUTTING AWAY THE TRAY AND THE INSTRUMENTS AFTER A RESTORATIVE PROCEDURE. THE SYRINGE ROLLED OFF THE TRAY AND SHE TRIED TO CATCH IT, BUT THE CAP CAME OFF AND SHE WAS STRUCK BY THE NEEDLE THROUGH THE GLOVE AS SHE GRABBED IT. SHE PUNCTURED HER FINGER THROUGH THE GLOVE WHEN SHE GRABBED THE SYRINGE. OTHER INFORMATION OF PRODUCT: BATCH#: F10725AA, EXPIRY DATE: 31-AUG-2026. CORRECTIVE TREATMENT: THE DENTAL ASSISTANT HAD 3 VISITS TO CLINICS FOR EXAM, VACCINATION AND BLOOD TESTING, SINCE THE NEEDLE WAS A USED/CONTAMINATED NEEDLE. BLOOD WORK WAS PERFORMED. THE DENTAL ASSISTANT HAD A FOLLOW-UP BLOOD WORK AND WAS ADMINISTERED HEPATITIS VACCINE. THIS CASE WAS CONSIDERED SERIOUS BY THE COMPANY WITH SERIOUSNESS CRITERIA "OTHER MEDICALLY IMPORTANT CONDITION" FOR PT "EXPOSURE TO CONTAMINATED DEVICE". FOLLOW-UP #1 RECEIVED ON 28-JUL-2023: ADDITIONAL INFORMATION PROVIDED REGARDING THE PATIENT (INITIALS, AGE, DATE OF BIRTH AND MEDICAL HISTORY). FOLLOW-UP #2 RECEIVED ON 07-AUG-2023: ADDITIONAL INFORMATION PROVIDED REGARDING THE QUALITY INVESTIGATION. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED A DETACHMENT OF THE NEEDLE PROTECTIVE CAP LEADING TO ACCIDENTAL NEEDLE STICK. IN THIS CASE, THE CAP CAME OFF AFTER THE DENTAL PROCEDURE WAS PERFORMED IN A CONTEXT OF FALLING SYRINGE, SO IT MAY HAVE BEEN BADLY RECAPPED. HOWEVER, A DETACHMENT OF THE PROTECTIVE CAP COULD BE DUE TO A QUALITY DEFECT OF THE DEVICE SUCH AS INCORRECT DIMENSION OF THE OUTER DIAMETER OF THE CAP. THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, NO ROOT CAUSE COULD BE DETERMINED. A USE ERROR OR ABNORMAL USE WAS NOT EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1025259 | HENRY SCHEIN PREMIUM NEEDLES 27GA SHORT | NEEDLE, DENTAL | DZM | SOFIC | F10725AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Other |