MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for IV START KIT manufactured by Medical Action Industries, Inc..
[41328522]
Patient Sequence No: 1, Text Type: N, H10
[41328523]
After pinching the barrel of the chloraprep sepp included in the medical actions iv start kit the outer plastic covering the barrel broke and sharp shards protruded, cutting the nurse involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5531301 |
| MDR Report Key | 5531301 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-02-19 |
| Date of Event | 2015-12-07 |
| Report Date | 2015-12-09 |
| Date Reported to FDA | 2015-12-09 |
| Date Reported to Mfgr | 2015-12-09 |
| Date Added to Maude | 2016-03-29 |
| 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 |
| 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 | 2016-03-29 |
| 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 RD. ARDEN, NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-29 |