MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for ULTRACLAMP TUBING CLAMP 5C4957 manufactured by Baxter Healthcare - Cleveland.
[134592710]
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[134592711]
This report summarizes one malfunction events. It was reported that an ultraclamp tubing clamp came loose, leading to a leak of solution. This event involved a patient with no patient consequences. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-00426 |
| MDR Report Key | 8291323 |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-30 |
| Date Mfgr Received | 2018-12-31 |
| Date Added to Maude | 2019-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - CLEVELAND |
| Manufacturer Street | 911 HIGHWAY 61 NORTH PO BOX 1058 |
| Manufacturer City | CLEVELAND MS 38732 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38732 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRACLAMP TUBING CLAMP |
| Generic Name | CLAMP, LINE |
| Product Code | FKK |
| Date Received | 2019-01-30 |
| Model Number | NA |
| Catalog Number | 5C4957 |
| Lot Number | ASKU |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CLEVELAND |
| Manufacturer Address | CLEVELAND MS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |