MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-29 for IV START KIT 267014 manufactured by Medical Action Industries, Inc..
[34549349]
Patient Sequence No: 1, Text Type: N, H10
[34549350]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5331661 |
| MDR Report Key | 5331661 |
| Date Received | 2015-12-29 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-11-19 |
| Report Date | 2015-11-19 |
| Date Reported to FDA | 2015-11-19 |
| Date Reported to Mfgr | 2015-11-19 |
| Date Added to Maude | 2015-12-29 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV START KIT |
| Generic Name | KIT, I.V. START |
| Product Code | LRS |
| Date Received | 2015-12-29 |
| Catalog Number | 267014 |
| Lot Number | 213752 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-29 |