MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for BIOGUARD AIR/WATER AND SUCTION VALVES 00711780 manufactured by United States Endoscopy Group, Inc..
[130502451]
The single use bioguard air/water & suction valve is used to control the air / water function of an endoscope during gi endoscopic procedures. The user was not using facial ppe and was struck on the cheek by a portion of the device. The device includes a spring-loaded valve cap. Device breakage during use may result in release of the spring or cap. The device subject of this event was not returned to us endoscopy for evaluation. The device subject of this event was a component of a via compliance kit ((b)(4)). The device history record was reviewed and confirmed the bioguard was manufactured to specification. There have been no other complaints associated with this lot. The instructions for use include the following statements: "inspect the package for shipping or handling damage. If damage is evident, do not use these devices. Confirm that the valve fits securely and that there is no gap between the valve end cap and the endoscope. Actuate the valve by pressing and releasing a few times to confirm smooth function. ". In-service training was completed on 11/19/2018; there have been no further issues reported since.
Patient Sequence No: 1, Text Type: N, H10
[130502452]
The user facility reported that the bioguard air/water & suction valve device became disassembled during use, causing a portion the valve to strike a user. No injury was reported, and no treatment was sought or administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00040 |
| MDR Report Key | 8161294 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2018-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. COLETTA COHARA |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403586251 |
| Manufacturer G1 | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOGUARD AIR/WATER AND SUCTION VALVES |
| Generic Name | AIR/WATER AND SUCTION VALVES |
| Product Code | ODC |
| Date Received | 2018-12-13 |
| Model Number | 00711780 |
| Catalog Number | 00711780 |
| Lot Number | 1803021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-13 |