MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-16 for LIBERTY LINE PRODUCTS UDB901S manufactured by Li Enterprises.
[5161170]
Liberty line products, urinary drainage bag kit, lot# 13gc0194. Product removed from package with blood on connection port, bio-matter on inside of connector. This was a supposedly sterile package from vendor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038648 |
| MDR Report Key | 4189306 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-10-07 |
| Date of Event | 2014-10-06 |
| Date Added to Maude | 2014-10-22 |
| 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 | LIBERTY LINE PRODUCTS |
| Generic Name | URINARY DRAINAGE BAG WITH ANTI RELUX DEVICE STERILE |
| Product Code | FCN |
| Date Received | 2014-10-16 |
| Returned To Mfg | 2014-10-07 |
| Catalog Number | UDB901S |
| Lot Number | 13GC0194 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LI ENTERPRISES |
| Manufacturer Address | FREDERICK MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-16 |