MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-11-07 for T-CONNECTOR MX453 manufactured by Medex.
[16360682]
The "t" connector is separating from the back of the acuvance catheter. No pt injury or treatment associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526863-2003-00105 |
| MDR Report Key | 494639 |
| Report Source | 05 |
| Date Received | 2003-11-07 |
| Date of Report | 2003-10-09 |
| Date of Event | 2003-10-01 |
| Date Mfgr Received | 2003-10-09 |
| Date Added to Maude | 2003-11-13 |
| 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 | TERRI DAVIS |
| Manufacturer Street | 6250 SHIER-RINGS RD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-CONNECTOR |
| Generic Name | T-CONNECTOR |
| Product Code | FKB |
| Date Received | 2003-11-07 |
| Model Number | NA |
| Catalog Number | MX453 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 483351 |
| Manufacturer | MEDEX |
| Manufacturer Address | 6250 SHIER RINGS RD. DUBLIN OH 43016 US |
| Baseline Brand Name | T-CONNECTOR |
| Baseline Generic Name | T-CONNECTOR |
| Baseline Model No | NA |
| Baseline Catalog No | MX453 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-07 |