MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for MICROGUARD IIB FILTER KIT MICROGARD IIB FILTER KIT V-892391 manufactured by Vyaire Medical, Inc.
[80411445]
Vyaire medical file identification: (b)(4). (b)(4). At this time, carefusion has not received the suspect device/component for evaluation. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[80411446]
An end user reported to vyaire medical that a nose clip broke when being squeezed for placement on a patient and the end user was struck in the face by one half of the nose clip when it broke. The end user reported that they received a scratch as a result of being hit in the face with the broken clip but did not seek medical treatment. There was no impact to patients associated with the problem reported to vyaire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00355 |
| MDR Report Key | 6720318 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2017-07-17 |
| 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 | 3 |
| Manufacturer Contact | KRISTIN GRAF |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | LEIBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICROGUARD IIB FILTER KIT |
| Generic Name | CLIP, NOSE |
| Product Code | BXJ |
| Date Received | 2017-07-17 |
| Model Number | MICROGARD IIB FILTER KIT |
| Catalog Number | V-892391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | LEIBNIZSTRASSE 7 HOECHBERG GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-17 |