ATELLICA VTR SYRINGE
Report
- Report Number
- 2028807-2024-00070
- Event Type
- Malfunction
- Date Received
- November 21, 2024
- Date of Event
- October 22, 2024
- Report Date
- January 20, 2025
- Manufacturer
- WESTMED LLC
- Product Code
- CBT
- UDI-DI
- 00709078013362
- PMA / PMN Number
- K822786
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 21 NOV 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 062222N25 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE REPORTED EVENT COULD NOT BE CONFIRMED AS REPORTED; THE ROOT CAUSE IS UNDETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 20 JAN 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
IT WAS REPORTED, BLOOD SPLATTERED INTO AN OPERATOR'S EYE WHILE EXPELLING AIR FROM AN ATELLICA VTR SYRINGE; THERE WAS NO REPORTED INJURY. ADDITIONALLY, IT WAS NOTED THE PATIENTS BLOOD WAS KNOWN TO CONTAIN BLOOD BORNE PATHOGENS AND TESTING CONTINUES FOR BLOOD BORNE PATHOGENS AND RELEVANT TREATMENT THEREAFTER. THE CURRENT CONDITION OF THE OPERATOR WAS NOT REPORTED.
IT WAS REPORTED, BLOOD SPLATTERED INTO AN OPERATOR'S EYE WHILE EXPELLING AIR FROM AN ATELLICA VTR SYRINGE; THERE WAS NO REPORTED INJURY. ADDITIONALLY, IT WAS NOTED THE PATIENTS BLOOD WAS KNOWN TO CONTAIN BLOOD BORNE PATHOGENS AND TESTING CONTINUES FOR BLOOD BORNE PATHOGENS AND RELEVANT TREATMENT THEREAFTER. THE CURRENT CONDITION OF THE OPERATOR WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1777328 | ATELLICA VTR SYRINGE | 1ML A-LINE ASPIRATING LUER SLIP SYRINGE | CBT | WESTMED LLC | 11561341 | 062222N25 | 00709078013362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |