MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-01-23 for CLAMP SHORT NOSE FOR OUTLETPORT 5C4527 manufactured by Baxter Healthcare - Swinford.
[22054171]
(b)(4). The actual sample was received and evaluated. The reported condition was confirmed. The lot number was not provided; therefore a batch review was not conducted. Similar reports have been received by baxter for the reported problemno root cause relating to the manufacturing process has been determined and no corrective actions have been identified. 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.
Patient Sequence No: 1, Text Type: N, H10
[22091977]
A customer reported to baxter (b)(4) that upon initial use of the clamp it was easily broken. The reporter went the hospital to test the blue clamp. He used normal strength to open the clamp and found 3 clamps were broken in ten units during the test. There was no patient involvement. No patient injury or medical intervention was reported along with this complaint. This is report 2 of 3.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2011-00930 |
| MDR Report Key | 1968276 |
| Report Source | 01,07 |
| Date Received | 2011-01-23 |
| Date of Report | 2010-12-30 |
| Date of Event | 2010-12-29 |
| Date Mfgr Received | 2010-12-30 |
| Date Added to Maude | 2011-10-25 |
| 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 | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE - SWINFORD |
| Manufacturer Street | FOXFORD ROAD |
| Manufacturer City | SWINFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLAMP SHORT NOSE FOR OUTLETPORT |
| Generic Name | CLAMP, LINE |
| Product Code | FKK |
| Date Received | 2011-01-23 |
| Catalog Number | 5C4527 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-01-23 |