MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for CARDINAL HEALTH IV START KIT WITH CHLORAPREP manufactured by Cardinal Health 200, Llc.
[53726451]
Patient Sequence No: 1, Text Type: N, H10
[53726452]
Patient for a ct. Outpatient diagnostic imaging (di) reports that while prepping skin w/chloraprep from an unopened iv start kit, patient noted pain. A scratch was noted and upon inspection of the chloraprep sponge, glass was noted to be sticking out of the sponge. The right antecubital (rac) wound produced several specks of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5920487 |
| MDR Report Key | 5920487 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-19 |
| Report Date | 2016-08-19 |
| Date Reported to FDA | 2016-08-19 |
| Date Reported to Mfgr | 2016-08-19 |
| Date Added to Maude | 2016-09-01 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL HEALTH IV START KIT WITH CHLORAPREP |
| Generic Name | KIT, I.V. START |
| Product Code | LRS |
| Date Received | 2016-09-01 |
| Lot Number | 393552 |
| Device Expiration Date | 2018-10-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HIGHWAY FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-01 |