MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-09-30 for ULTRACLAMP TUBING CLAMP 5C4957 manufactured by Baxter Healthcare - Cleveland.
[3926136]
It was reported by a home patient (hp) that an ultraclamp did not effectively clamp the bags, allowing fluid to pass through the tubing. No patient injury or medical intervention was indicated in association with this report. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[11221446]
(b)(4). The devices were not available for evaluation. A review of all batch record documents for lot number gd894121 was performed with no issues noted during the manufacturing process. There were no deviations from standard procedure and no exceptions related to the reported condition were noted. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2013-26575 |
| MDR Report Key | 3376298 |
| Report Source | 04,07 |
| Date Received | 2013-09-30 |
| Date of Report | 2013-09-06 |
| Date Mfgr Received | 2013-09-06 |
| Device Manufacturer Date | 2013-02-14 |
| Date Added to Maude | 2014-01-06 |
| 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 | 2013-09-30 |
| Catalog Number | 5C4957 |
| Lot Number | GD894121 |
| Device Expiration Date | 2018-01-29 |
| 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 | 2013-09-30 |