MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2014-01-28 for ULTRACLAMP TUBING CLAMP 5C4957 manufactured by Baxter Healthcare - Cleveland.
[4064980]
It was reported that an ultra clamp did? Not hold well.? The reporter stated that a drainage bag leaked when clamped with the device. It was not specified when in the process this occurred. It is unknown if there was patient involvement; however, 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
[11533136]
(b)(4). The device was not returned and the lot number is unknown; therefore, an evaluation could not be conducted. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2014-02754 |
| MDR Report Key | 3595052 |
| Report Source | 01,04,07 |
| Date Received | 2014-01-28 |
| Date of Report | 2014-01-07 |
| Date of Event | 2014-01-06 |
| Date Mfgr Received | 2014-01-07 |
| Date Added to Maude | 2014-03-20 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTINA ARNT |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242703198 |
| Manufacturer G1 | BAXTER HEALTHCARE - CLEVELAND |
| Manufacturer Street | 911 HIGHWAY 61 NORTH PO BOX 1 |
| 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 | 2014-01-28 |
| Catalog Number | 5C4957 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CLEVELAND |
| Manufacturer Address | 911 HIGHWAY 61 NORTH PO BOX 1 CLEVELAND MS 38732 US 38732 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-28 |