ATELLICA VTR SYRINGES
Received Jul 3, 2025
Report 2028807-2025-00016 · MDR key 22398577
Device
Generic name
3ml Vented Luer Slip Syringe, (50iu)16.7iu/ml Balanced Heparin, Vented Tip Cap
Manufacturer
Westmed LlcModel number
11561344Catalog number
NA
Lot number
403650
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: NA INVESTIGATION CONCLUSION: D4; H6 THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION; ADDITIONALLY, NO PHOTOS OR VIDEO EVIDENCE WERE PROVIDED. WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION OR PHOTOGRAPHIC /VIDEO EVIDENCE THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 403650 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW. ALL INFORMATION REASONABLY KNOWN AS OF 03 JUL 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.
Description of Event or Problem
IT WAS REPORTED, BLOOD SPLASHED ONTO A NURSE'S FACE AND ARMS WHILE PUSHING BLOOD INTO A 3CC-50U VENTED & VENTED TIP CAP LS SYRINGE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 04APR2025 REPORTED, THERE WAS NO EVIDENCE OF DAMAGE TO THE SYRINGE; THE BLOOD SPLASH OCCURRED WHEN AN ATTEMPT TO VENT THE SYRINGE WAS PERFORMED. IT WAS ADDITIONALLY REPORTED, THE SYRINGE 'LOOKED NORMAL'. THERE WAS NO REPORTED INJURY.