EP STERILE PACK - LABEL SHEET
Received Oct 20, 2011
Report 2320701 · MDR key 2320701
Device
Product problems
- Contamination
- Material Deformation
Patient
69 YR
- No Information
Narrative
Description of Event or Problem
IT IS STANDARD TO HAVE A BOWL OF HEPARNIZED SALINE ON THE TABLE FOR FLUSHING CATHETERS. SYRINGES ARE LABELED WITH LABELS THAT ARE SUPPLIED IN THE PACK. THE LABELS BEGAN DISSOLVING IN THE HEPARNIZED SALINE. DURING USE THE LABELS WERE SUCKED UP INTO THE SYRINGE. THE TECH CAUGHT THE ISSUE BEFORE IT WAS USED ON THE PATIENT. STERILE LABELS PROVIDED IN PACKS ARE NOT IMPERMEABLE ~ DISSOLVED IN HEPARINIZED SALINE FLUSH.