MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-02 for ST JUDE COOL POINT TUBING 85785 manufactured by Irvine Biomedical, Inc..
[182223082]
Upon spiking heparinized saline flush bag to prime tubing, product found to have crack in tubing, creating an area where fluid would leak. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093478 |
| MDR Report Key | 9779757 |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-17 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ST JUDE COOL POINT TUBING |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-03-02 |
| Catalog Number | 85785 |
| Lot Number | H1742412 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE BIOMEDICAL, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |