MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-04 for VITAL*VUE 8886828206 manufactured by Covidien, Formerly Us Surgical A Divison Of Tyco Healthcare.
[3105714]
Opened sterile product & saw a hair wrapped around a ball of lint intertwined in tubing. Product was removed from the sterile field and another one opened. This product had no contact with the patient. Manufacturer response for vitalvue suction hand piece, vital*vue (per site reporter)took down description of problem, issued complaint # xxx and are sending a return kit so product can be returned for inspection... Rec'd return kit & shipped out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2890526 |
| MDR Report Key | 2890526 |
| Date Received | 2012-12-04 |
| Date of Report | 2012-11-28 |
| Date of Event | 2012-11-07 |
| Report Date | 2012-11-28 |
| Date Reported to FDA | 2012-12-04 |
| Date Added to Maude | 2012-12-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL*VUE |
| Generic Name | CATHETER AND TIP, SUCTION |
| Product Code | HBI |
| Date Received | 2012-12-04 |
| Returned To Mfg | 2012-12-04 |
| Model Number | * |
| Catalog Number | 8886828206 |
| Lot Number | 122270126 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-04 |