MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-09-25 for ADULT WATER TRAP W/CLAMP 5276 manufactured by Cardinal Health.
[18158217]
Roll clamp would not properly stay closed causing a leak in the system. Pt started to desaturate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00119 |
| MDR Report Key | 486688 |
| Report Source | 05,06 |
| Date Received | 2003-09-25 |
| Date of Report | 2003-09-25 |
| Date Mfgr Received | 2003-08-26 |
| Date Added to Maude | 2003-10-06 |
| 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 | PARTICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | CARDINAL HEALTH |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85 |
| Manufacturer City | MEXICALLI 21600 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT WATER TRAP W/CLAMP |
| Generic Name | WATER TRAP |
| Product Code | BYH |
| Date Received | 2003-09-25 |
| Model Number | 5276 |
| Catalog Number | 5276 |
| Lot Number | Y2P0869 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 475574 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | ADULT WATER TRAP W/CLAMP |
| Baseline Generic Name | WATER TRAP |
| Baseline Model No | 5276 |
| Baseline Catalog No | 5276 |
| Baseline ID | NA |
| Baseline Device Family | ACCESSORY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-09-25 |