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 2006-08-03 for MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP 5C4482 manufactured by Baxter Healthcare Corporation.
[499925]
Baxter reports that the two components of the twist clamp were lightly broken, and that the break was almost not detectable. There was no pt injury or medical intervention associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
[7837751]
Evaluation summary: results indicate that the lab was not able to confirm the reported event. There are no further measures taken relative to this matter. Renal product surveillance, quality engineering, along with plant manufacturing, will continue to monitor this product line.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2006-00904 |
| MDR Report Key | 763972 |
| Report Source | 01,04,07 |
| Date Received | 2006-08-03 |
| Date of Report | 2006-07-06 |
| Date of Event | 2006-07-04 |
| Date Mfgr Received | 2006-07-06 |
| Date Added to Maude | 2006-09-26 |
| 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 | 0 |
| Manufacturer Contact | KAREN KIRBY, MANAGER |
| Manufacturer Street | ROUTE 120 & WILSON RD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8477204541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORP |
| Manufacturer Street | 1900 HIGHWAY, 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653231 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2314 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP |
| Generic Name | TRANSFER SET |
| Product Code | KJJ |
| Date Received | 2006-08-03 |
| Returned To Mfg | 2006-07-28 |
| Model Number | NA |
| Catalog Number | 5C4482 |
| Lot Number | NA01 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 751845 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | * MOUNTAIN HOME AR 72653 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-03 |