MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for NEONATAL PROCEDURE TRAY 384835 manufactured by Argon Medical Devices, Inc..
[133850954]
The neonatal nurse practitioner went to place a picc on a patient in nicu. Upon setting up the sterile field and opening the neonatal procedure tray picc catheters for placement of neonatal from argon medical devices, inc. , she noticed contaminant on the sterile instruments. She immediately stopped the process of setting up the sterile field. The packaging and instruments were pulled from the field. Nicu had the contaminant tested and found out that it was bioburden.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8270366 |
| MDR Report Key | 8270366 |
| Date Received | 2019-01-23 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-29 |
| Report Date | 2018-12-11 |
| Date Reported to FDA | 2018-12-11 |
| Date Reported to Mfgr | 2019-01-23 |
| Date Added to Maude | 2019-01-23 |
| 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 | RISK MANAGER |
| 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 | NEONATAL PROCEDURE TRAY |
| Generic Name | PERIPHERAL CATHETER INSERTION KIT |
| Product Code | OWL |
| Date Received | 2019-01-23 |
| Model Number | 384835 |
| Catalog Number | 384835 |
| Lot Number | 11221241 |
| Device Availability | * |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-23 |