MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2001-10-26 for RUSCH E3420 manufactured by Rusch Inc..
[236641]
The customer reports that after flushing and recapping the tubes are leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-2001-00189 |
| MDR Report Key | 359147 |
| Report Source | 06,08 |
| Date Received | 2001-10-26 |
| Date of Report | 2001-10-24 |
| Date Mfgr Received | 2001-10-22 |
| Date Added to Maude | 2001-11-08 |
| 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 | DONNA MCLEOD |
| Manufacturer Street | 2450 MEADOWBROOK PARKWAY |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal | 30096 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH |
| Generic Name | 3 PORT "G" TUBES |
| Product Code | KDH |
| Date Received | 2001-10-26 |
| Model Number | NA |
| Catalog Number | E3420 |
| Lot Number | 104545 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 348318 |
| Manufacturer | RUSCH INC. |
| Manufacturer Address | 2450 MEADOWBROOK PARKWAY DULUTH GA 30096 US |
| Baseline Brand Name | TRIPLEPORT GASTROSTOMY CATHETER-20 FR |
| Baseline Model No | NA |
| Baseline Catalog No | E3420 |
| Baseline ID | NA |
| Baseline Device Family | GASTROSTOMY CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K891371 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-26 |