MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-01 for CHLORAPREP, FREPP * 260299 manufactured by Mediflex, Inc..
[21254092]
Prepping left arm for iv insertion. Chloroprep was used to prep site. There was cracked glass tube in the chloroprep. Cleansed the site and noted bleeding at the site immediately afterward.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 854694 |
| MDR Report Key | 854694 |
| Date Received | 2007-05-01 |
| Date of Report | 2007-04-30 |
| Date of Event | 2007-04-29 |
| Report Date | 2007-04-30 |
| Date Reported to FDA | 2007-05-01 |
| Date Added to Maude | 2007-05-24 |
| 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 | CHLORAPREP, FREPP |
| Generic Name | SKIN PREPARATION, ANTISEPTIC |
| Product Code | KOY |
| Date Received | 2007-05-01 |
| Model Number | * |
| Catalog Number | 260299 |
| Lot Number | 702367 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 840274 |
| Manufacturer | MEDIFLEX, INC. |
| Manufacturer Address | 11400 TOMAHAWK CREEK PARKWAY LEAWOOD KS 66211 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-01 |