N
Patient 1
MAUDE MDR 5999514
- MDR report key
- 5999514
- Report number
- 5999514
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-08
- Date received
- 2016-10-05
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | I.V. START KIT | LSL INDUSTRIES, INC. | LRS | 3272 | 3272 | 6G3014 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-10-05 | 0 |
Event Narratives#
D
Patient 1
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.