MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-03-12 for VIASYS MOUTHPIECES, LARGE 42157 manufactured by Carefusion.
[15499791]
The following description of the event was documented by a carefusion tech support specialist in response to a phone conversation with user facility representative. "[name removed] has used these mouthpieces for a long time. The past three orders he has noticed that they are cut incorrectly and missing much of the mylar coating of the mouthpiece. He states about ten patients between the ages of (b)(6 have ended up with bloody lips after removing their lips from the mouthpiece. This includes himself which he is the biological standard for the lab. He is using a medgraphics system, but orders mouthpieces from us. "
Patient Sequence No: 1, Text Type: D, B5
[15725847]
The user facility did not submit a user facility report to the manufacturer. (b)(4): samples of the alleged faulty device were received on (b)(4) 2010 and were routed into the carefusion failure analysis lab and are in the queue awaiting evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2010-00008 |
| MDR Report Key | 1631197 |
| Report Source | 06 |
| Date Received | 2010-03-12 |
| Date of Report | 2010-03-09 |
| Date of Event | 2010-02-10 |
| Date Facility Aware | 2010-02-10 |
| Date Mfgr Received | 2010-02-10 |
| Date Added to Maude | 2011-01-24 |
| 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 | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES STYTLE |
| Manufacturer Phone | 7608837120 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIASYS |
| Generic Name | BYP MOUTHPIECE, BREATHING |
| Product Code | BYP |
| Date Received | 2010-03-12 |
| Model Number | MOUTHPIECES, LARGE |
| Catalog Number | 42157 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-12 |