MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-09-15 for SAFETY DRAIN 131 manufactured by Kimberly-clark/ Ballard.
[634016]
An incident report was received through the kimberly-clark sales rep on behalf of the user facility. The safety drain devices had leaks at the suction port and caused pressure loss. One pt went into bradycardia with peep (positive end expiratory pressure) of 18 and fio2 at 80 percent. The pt was removed from the ventilator and hand bagged until the safety drain could be replaced. During that time, the ventilator was inoperative. Add'l incident related pt medical problems or other pt issues were not cited. Kimberly-clark or ballard medical has no first hand knowledge of the allegations but is relaying info received from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
[7813147]
The manufacture of this product line is in the process of being relocated, along with the associated testing equipment. Until the equipment is validated and the returned devices can be thoroughly tested, no conclusion can be drawn at this time. A supplemental report will be filed with the test results when the evaluations have been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3031042-2006-00044 |
| MDR Report Key | 879043 |
| Report Source | 06,07 |
| Date Received | 2006-09-15 |
| Date of Report | 2006-09-15 |
| Date of Event | 2006-08-18 |
| Date Mfgr Received | 2006-08-18 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-07-12 |
| 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 | SALLY HERRICK |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877244 |
| Manufacturer G1 | * |
| Manufacturer Street | 1999 ALVIN RICKEN DR |
| Manufacturer City | POCATELLO ID 83201 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 83201 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY DRAIN |
| Generic Name | DRAIN, TEE (WATER TRAP) |
| Product Code | BYH |
| Date Received | 2006-09-15 |
| Returned To Mfg | 2006-09-08 |
| Model Number | NA |
| Catalog Number | 131 |
| Lot Number | 354907 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 858309 |
| Manufacturer | KIMBERLY-CLARK/ BALLARD |
| Manufacturer Address | * POCATELLO ID * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-15 |