MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-10 for ULTRACLAMP TUBING CLAMP 5C4957 manufactured by Baxter Healthcare Corporation.
[174621468]
The device was received and is currently awaiting evaluation. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174621469]
It was reported an ultraclamp tubing clamp was leaking from an unspecified location. It was further reported that the red clamp did not fully close off the tube and fluid leaked on the floor. The leak was discovered during use for peritoneal dialysis therapy. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[179668305]
Three actual sample were received for evaluation. A visual inspection was performed with the naked eye and stress marks were detected on all three actual complaint samples. The samples opened and closed as expected. During sample analysis, no additional complaints defects, or use errors were identified during testing/analysis. The reported condition was not verified. The cause of the condition could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07510 |
| MDR Report Key | 9578040 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-02 |
| Date Added to Maude | 2020-01-10 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | 3 |
| Brand Name | ULTRACLAMP TUBING CLAMP |
| Generic Name | CLAMP, LINE |
| Product Code | FKK |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-01-09 |
| Model Number | NA |
| Catalog Number | 5C4957 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |