N
Patient 1
MAUDE MDR 5331661
- MDR report key
- 5331661
- Report number
- 5331661
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-11-19
- Date received
- 2015-12-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IV START KIT | KIT, I.V. START | MEDICAL ACTION INDUSTRIES, INC. | LRS | 267014 | 213752 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-12-29 | 0 | 1. O |
Event Narratives#
D
Patient 1
IN PATIENT'S ROOM TO START IV. NURSE USED CHLORAPREP PROVIDED IN IV START KIT TO CLEAN PATIENT'S ARM PRIOR TO IV INSERTION AND CHLORAPREP RESULTED IN TWO LINEAR ABRASIONS TO PATIENT'S RIGHT ANTECUBITAL AREA. CHLORAPREP LOT# 88663 ON ACTUAL CHLORAPREP, HOWEVER KIT LOT# IS 213752.