MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-09-27 for T CONNECTOR WITH MALE LUER SLIP MX453 manufactured by Medex.
[200258]
The customer initially reported that the t-connector leaked at the tubing and the t-site. During in-house eval, it was determined that the tubing was cut. No pt injury or treatment was associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526863-2000-00116 |
| MDR Report Key | 298677 |
| Report Source | 05 |
| Date Received | 2000-09-27 |
| Date of Report | 2000-09-25 |
| Date of Event | 2000-09-25 |
| Date Mfgr Received | 2000-09-25 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2000-10-04 |
| 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 | BARBARA LAW |
| Manufacturer Street | 6250 SHIER-RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915568 |
| Manufacturer G1 | MEDEX |
| Manufacturer Street | 6250 SHIER-RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T CONNECTOR WITH MALE LUER SLIP |
| Generic Name | T CONNECTOR |
| Product Code | FKB |
| Date Received | 2000-09-27 |
| Model Number | NA |
| Catalog Number | MX453 |
| Lot Number | 29B160048 |
| 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 | 289113 |
| 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 | 2000-09-27 |