MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-09-20 for T-CONNECTOR MX453 manufactured by Medex.
[209302]
The reporter stated that they have had sets crack at the hub. Tpn and lipids were being infused. There was no injury or treatment associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526863-2001-00086 |
| MDR Report Key | 352980 |
| Report Source | 05 |
| Date Received | 2001-09-20 |
| Date of Report | 2001-08-24 |
| Date Mfgr Received | 2001-08-24 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2001-09-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TERRI DAVIS |
| Manufacturer Street | 6250 SHIER-RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | MEDEX |
| Manufacturer Street | 11360 TECHNOLOGY CIRCLE |
| Manufacturer City | DULUTH GA 30097 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30097 |
| 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 | 2001-09-20 |
| Model Number | NA |
| Catalog Number | MX453 |
| Lot Number | 31E140044 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 342235 |
| 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 | MX253 |
| Baseline ID | NA |
| Baseline Device Family | CONNECTORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K790408 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-09-20 |