MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-09-18 for DOUBLE T-CONNECTOR WITH 4 INCH EXTENSION SET MX453H2L manufactured by Medex.
[295164]
The reporter stated that the male luer broke off when trying to connect. No patient injury or treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526863-2003-00090 |
| MDR Report Key | 485746 |
| Report Source | 00 |
| Date Received | 2003-09-18 |
| Date of Report | 2003-08-28 |
| Date Mfgr Received | 2003-08-28 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2003-10-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | DOUBLE T-CONNECTOR WITH 4 INCH EXTENSION SET |
| Generic Name | T-CONNECTOR |
| Product Code | FKB |
| Date Received | 2003-09-18 |
| Model Number | NA |
| Catalog Number | MX453H2L |
| Lot Number | 33D070097 |
| 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 | 474631 |
| Manufacturer | MEDEX |
| Manufacturer Address | 6250 SHIER RINGS RD. DUBLIN OH 43016 US |
| Baseline Brand Name | NON-DEHP DOUBLE T-CONNECTION 4 INCH EXTENSION SET |
| Baseline Generic Name | T-CONNECTOR |
| Baseline Model No | NA |
| Baseline Catalog No | MX453H2L |
| 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 | 2003-09-18 |