MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-07-02 for MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP 5C4482 manufactured by Baxter Healthcare Corp..
[16406975]
Rn reports a home pt observed a leak from the tip of a transfer set when the clamp was in the closed position. The transfer set was 5 months old. The pt received a transfer set change by rn and was treated prophylactically with duricef 500 mg, by mouth, twice daily for 3 days. No pt injury was associated with this report per rn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2002-00815 |
| MDR Report Key | 407736 |
| Report Source | 05 |
| Date Received | 2002-07-02 |
| Date of Report | 2002-06-06 |
| Date of Event | 2002-06-04 |
| Date Mfgr Received | 2002-06-06 |
| Date Added to Maude | 2002-07-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTIANA BIELINSKI |
| Manufacturer Street | ONE BAXTER PARKWAY |
| Manufacturer City | DEERFIELD IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal | 60015 |
| Manufacturer Phone | 8479483236 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 1900 HIGHWAY, 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653249 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2497 |
| 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 | KDJ |
| Date Received | 2002-07-02 |
| Returned To Mfg | 2002-06-11 |
| 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 | 396719 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 1900 HIGHWAY, 201 NORTH MT. HOME AR 726532497 US |
| Baseline Brand Name | MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP |
| Baseline Generic Name | TRANSFER SET |
| Baseline Model No | NA |
| Baseline Catalog No | 5C4482 |
| Baseline ID | NA |
| Baseline Device Family | CAPD TRANSFER SET |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882498 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-07-02 |