MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-20 for EP STERILE PACK - LABEL SHEET * manufactured by Medline Industries.
[16923816]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320701 |
| MDR Report Key | 2320701 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-09-30 |
| Report Date | 2011-09-30 |
| Date Reported to FDA | 2011-10-20 |
| Date Added to Maude | 2011-11-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EP STERILE PACK - LABEL SHEET |
| Generic Name | LABEL SHEET |
| Product Code | LYV |
| Date Received | 2011-10-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 11DB5727 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | 1170 NORTHPOINT BLVD. PARK CITY IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-20 |