MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for ULTRACLAMP TUBING CLAMP 5C4957 manufactured by Baxter Healthcare - Cleveland.
[113229779]
This event occurred on an unspecified date in (b)(6) 2018. 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
[113229780]
It was reported that an ultraclamp tubing clamp caused a hole on the drain tubing during use. The home patient stated that while clamping the drain line to weigh the drain bag, the fluids were leaking out where the red clamp was. 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
[115208231]
Actual device was not returned. The device was manufactured from 03/01/2018 - 03/07/2018. The actual device was not available; however, a companion of the sample was provided for evaluation. A visual inspection was performed with no issues noted. Functional testing including clamp function and device testing was performed with no issues. The reported issue was not verified. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[115208232]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-03971 |
| MDR Report Key | 7652779 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-07-26 |
| Date Mfgr Received | 2018-07-16 |
| Date Added to Maude | 2018-06-29 |
| 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 | 0 |
| Brand Name | ULTRACLAMP TUBING CLAMP |
| Generic Name | CLAMP, LINE |
| Product Code | FKK |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-06-08 |
| Model Number | NA |
| Catalog Number | 5C4957 |
| Lot Number | GD904854 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CLEVELAND |
| Manufacturer Address | CLEVELAND MS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |