FDA Adverse Event
Summary report: N
EP STERILE PACK - LABEL SHEET
MDR report key: 2320701
·
Received October 20, 2011
Report
- Report Number
- 2320701
- Date Received
- October 20, 2011
- Report Date
- September 30, 2011
- Manufacturer
- MEDLINE INDUSTRIES
- Product Code
- LYV
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EP STERILE PACK - LABEL SHEET | LABEL SHEET | LYV | MEDLINE INDUSTRIES | * | 11DB5727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |