MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for IV START KIT 50390KP manufactured by Trinity Sterile.
[19033417]
Upon opening iv start kit 50390kp in front of the patient to start her iv, a foreign body was identified stuck to the chlorhexidine packet. Packaging and product with foreign object provided to manager and given to supply chain to notify vendor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044862 |
| MDR Report Key | 4949678 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-23 |
| Date of Event | 2015-07-22 |
| Date Added to Maude | 2015-07-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV START KIT |
| Generic Name | IV START KIT |
| Product Code | LRS |
| Date Received | 2015-07-23 |
| Model Number | 50390KP |
| Lot Number | 01152657 |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRINITY STERILE |
| Manufacturer Address | SALISBURY MD 21801 US 21801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-23 |