MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for IV START KIT manufactured by Medical Action Industries, Inc..
[50081517]
Patient Sequence No: 1, Text Type: N, H10
[50081518]
The glass ampule for the application of chloraprep broke and exposed the patient to micro lacerations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5811740 |
| MDR Report Key | 5811740 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-06-07 |
| Report Date | 2016-06-24 |
| Date Reported to FDA | 2016-06-24 |
| Date Reported to Mfgr | 2016-06-24 |
| Date Added to Maude | 2016-07-21 |
| 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 | 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 | 2016-07-21 |
| Lot Number | 218863 |
| Device Expiration Date | 2018-11-30 |
| 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 RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-21 |