MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for IV START KIT 3272 manufactured by Lsl Industries, Inc..
[56509298]
Patient Sequence No: 1, Text Type: N, H10
[56509299]
A materials supply tech was opening bulk boxes of supplies, including iv starter kit. This particular sealed case had many dead insects on top of the product inside the case. The entire case was brought to the supervisor to report the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5999514 |
| MDR Report Key | 5999514 |
| Date Received | 2016-10-05 |
| Date of Report | 2016-09-08 |
| Date of Event | 2016-09-08 |
| Report Date | 2016-09-08 |
| Date Reported to FDA | 2016-09-08 |
| Date Reported to Mfgr | 2016-09-08 |
| Date Added to Maude | 2016-10-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | I.V. START KIT |
| Product Code | LRS |
| Date Received | 2016-10-05 |
| Model Number | 3272 |
| Catalog Number | 3272 |
| Lot Number | 6G3014 |
| Device Expiration Date | 2018-04-01 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSL INDUSTRIES, INC. |
| Manufacturer Address | 5535 N. WOLCOTT AVE. CHICAGO IL 60640 US 60640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-05 |