MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-21 for WATER TRAP RAINTRAP W/CLP N/S 5276 * manufactured by Cardinal Health.
[7930441]
According to info provided by the customer, the watertrap was used with a non cardinal hlth ventilator circuit (non-heated wire) and it was noted that the clamp was in the open position at the time of the reported incident. However, there is no info of the position of the water tap in the circuit, as to whether or not it was in the upright position during use, because if the clamp were in the open position and the water trap in the upright position, the water would have drained out of the water trap and would not have accumulated in the circuit. Samples of the clamp from current inventory were reviewed in accordance with our raw material spec and no problems were found related to the clamp. Our mfg process also reviewed, and no problems were found related to the issue reported. Therefore, without the sample or add'l info we are unable to determine if the water trap contributed to the reported incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2007-00137 |
| MDR Report Key | 974626 |
| Report Source | 06 |
| Date Received | 2007-12-21 |
| Date Mfgr Received | 2007-11-27 |
| Date Added to Maude | 2008-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | MICHELE DONALTCH |
| Manufacturer Street | 1430 WAUKEGAN RD. BLDG KB |
| Manufacturer City | MCGRAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | CARDINAL HELATH MEXICALI |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER TRAP RAINTRAP W/CLP N/S |
| Generic Name | WATER TRAP RAINTRAP W/CLP N/S |
| Product Code | BYH |
| Date Received | 2007-12-21 |
| Model Number | 5276 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 942838 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-21 |