MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-05-28 for OUTLET PORT CLAMP 5C4527 manufactured by Baxter Healthcare ? Swinford.
[9012956]
(b)(4). The complaint was not confirmed as no samples have been received for analysis. A root cause was not determined. The lot number is unknown; therefore a batch review cannot be performed. Baxter has conducted a trend review and found that similar reports have been received for the reported problem. Baxter will continue to monitor similar reports to determine if further actions are required.
Patient Sequence No: 1, Text Type: N, H10
[17873849]
A home patient (hp) reported that the clamps break very easily. A follow up was done via phone. The patient stated the new box of clamps is working fine. The patient was involved but there was no patient injury or medical intervention reported. This is report 2 of 3.
Patient Sequence No: 1, Text Type: D, B5
[17916756]
(b)(4). A 510(k) number will not be provided in the emdr as this product is manufactured for distribution outside of the u. S. And does not have a 510(k) number. However, it is being reported because it is same as or similar to product distributed within the u. S. The lot number was not provided; therefore a batch review cannot be conducted. The sample was discarded. Should additional information become available, a follow up mdr will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-06711 |
| MDR Report Key | 2106315 |
| Report Source | 04 |
| Date Received | 2011-05-28 |
| Date of Report | 2011-05-04 |
| Date of Event | 2011-05-01 |
| Date Mfgr Received | 2011-05-27 |
| Date Added to Maude | 2011-06-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | VIRGINIA MCKINNEY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472702835 |
| Manufacturer G1 | BAXTER HEALTHCARE ? SWINFORD |
| Manufacturer Street | FOXFORD ROAD |
| Manufacturer City | SWINFORD 72653 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | 72653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTLET PORT CLAMP |
| Generic Name | CLAMP, LINE |
| Product Code | FKK |
| Date Received | 2011-05-28 |
| Catalog Number | 5C4527 |
| 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 ? SWINFORD |
| Manufacturer Address | FOXFORD ROAD SWINFORD EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-28 |