inforMED

EP STERILE PACK - LABEL SHEET

Received Oct 20, 2011

Report 2320701 · MDR key 2320701

Device

Generic name

Label Sheet

Manufacturer

Medline Industries

Model number

*

Catalog number

*

Lot number

11DB5727

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.