MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-04-23 for NON-DEHP DOUBLE T-CONNECTOR 4 INCH EXTENSION SET MX453H2L manufactured by Medex.
[15739567]
The reporter stated that product is leaking at the rubber ends however during review of the returned product it was discovered that the unit was cracked. No patient treatment or injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526863-2004-00033 |
| MDR Report Key | 552392 |
| Report Source | 08 |
| Date Received | 2004-04-23 |
| Date of Report | 2004-03-24 |
| Date of Event | 2004-01-01 |
| Date Mfgr Received | 2004-03-24 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2004-11-01 |
| 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 | 3 |
| 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 ROAD |
| 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 | NON-DEHP DOUBLE T-CONNECTOR 4 INCH EXTENSION SET |
| Generic Name | T-CONNECTOR |
| Product Code | FKB |
| Date Received | 2004-04-23 |
| Model Number | NA |
| Catalog Number | MX453H2L |
| Lot Number | 32H200043 |
| 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 | 541943 |
| Manufacturer | MEDEX |
| Manufacturer Address | 6250 SHIER-RINGS RD. DUBLIN OH 40316 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 | 2004-04-23 |