MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-10-11 for SAFETY DRAIN 131 manufactured by Kimberly-clark / Avent.
[614617]
An incident report was received through the kimberly-clark sales representative on behalf of the user facility. The valve of the safety drain device did not close properly. Fluid sprayed the eyes of two employees. Information from the user facility stated that the drain valve of the safety drain device was sticking open and water spewing out if it as well as air from the ventilator leaking out. The user attempted to use a suction device to unstick the valve. This did not work and the user was sprayed in the face. The safety drain device was replaced with a new one but the user had to break the ventilatory circuit to do so. The user considered this action to be increased risk of possible ventilator associated infection to the patient. The employees that were splashed went to the employee health and flushed their eyes with water. No additional treatment was done and the employees had no residual effects. Kimberly-clark or ballard medical has no first hand knowledge of the allegations but is relaying information received from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
[7971148]
The returned device was visually examined and performance tested. The device malfunctioned as the port seal opened. Water in the cup portion of the device was able to come up through the pick-up tube and out the port seal opening, exiting the cup. An internal investigation is being conducted to determine the root cause. Input from a respiratory therapist consultant stated that if universal precautions had been followed, spraying of the eyes would not have occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611594-2006-00052 |
| MDR Report Key | 854617 |
| Report Source | 06,07 |
| Date Received | 2006-10-11 |
| Date of Report | 2006-10-11 |
| Date of Event | 2006-09-12 |
| Date Mfgr Received | 2006-09-12 |
| Date Added to Maude | 2007-05-24 |
| 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 ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877244 |
| Manufacturer G1 | * |
| Manufacturer Street | CIRCULTO INDUSTRIAL NO. 40 COLONIA OBRERA |
| Manufacturer City | NOGALES, SONORA, CP 84048 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84048 |
| 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 | 2006-10-11 |
| Returned To Mfg | 2006-10-10 |
| Model Number | NA |
| Catalog Number | 131 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 840189 |
| Manufacturer | KIMBERLY-CLARK / AVENT |
| Manufacturer Address | * NOGALES, SONORA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-11 |