MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for BAXTER -NON-DEHP THREE LEAD CATHETER EXTENSION SET 2N3342 manufactured by Baxter International Inc..
[131002455]
During the infusion of tpn product in the nicu it was noticed the tubing was leaking on the third day. The leaking was not in the connective part of the tubing. The tubing was due to be changed that day. There was no injury to the patient. There was no other medical follow-up necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8183985 |
| MDR Report Key | 8183985 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-11-30 |
| Report Date | 2018-12-14 |
| Date Reported to FDA | 2018-12-14 |
| Date Reported to Mfgr | 2018-12-20 |
| Date Added to Maude | 2018-12-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BAXTER -NON-DEHP THREE LEAD CATHETER EXTENSION SET |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2018-12-20 |
| Model Number | 2N3342 |
| Catalog Number | 2N3342 |
| Lot Number | (10) DR 18106024 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER INTERNATIONAL INC. |
| Manufacturer Address | 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |