MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2005-08-10 for 30" PRESSURE INJECTOR LINE MX683 manufactured by Medex.
[427299]
The reporter stated that the luer lock broke off of the tubing during the setup of the unit. No pt injury or treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616567-2005-00012 |
| MDR Report Key | 627919 |
| Report Source | 00,06 |
| Date Received | 2005-08-10 |
| Date of Report | 2005-07-11 |
| Date Mfgr Received | 2005-07-11 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-08-19 |
| 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 ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal | 43016 |
| Manufacturer Phone | 6147915542 |
| Manufacturer G1 | MEDEX DE MEXICO, SA |
| Manufacturer Street | CARRETERA MIGUEL ALEMAN KM 21.7 APODACA |
| Manufacturer City | MONTERREY 66600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 66600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 30" PRESSURE INJECTOR LINE |
| Generic Name | PRESSURE TUBING |
| Product Code | DYX |
| Date Received | 2005-08-10 |
| Returned To Mfg | 2005-07-27 |
| Model Number | NA |
| Catalog Number | MX683 |
| Lot Number | 34I03M009 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 617550 |
| Manufacturer | MEDEX |
| Manufacturer Address | 2231 RUTHERFORD ROAD CARLSBAD CA 92008 US |
| Baseline Brand Name | 30" PRESSURE INJECTOR LINE |
| Baseline Generic Name | PRESSURE TUBING |
| Baseline Model No | NA |
| Baseline Catalog No | MX683 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-10 |