MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for 03201 EYE PADS manufactured by Covidien.
[67113650]
A device history record review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures. A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues noted. All scheduled maintenance and calibration activities were completed on time. There were no related process or material changes related to the reported condition for this product or describe changes that occurred. (b)(6) sheets showed no issues for the date of production. A review of the machine setup was conducted and no issues were noted. Photos were provided for sample analysis. The photos indicated a small tear in the center of each pad within the seal toward the bottom of the package. The same tears are seen on multiple packages. On this machine, a chain with metal tabs carries the eyepad cutout from the cotton toward the paper to be packaged. As it approaches the area to be inserted between the paper, the metal tabs rotate along a roller and move out of the way to not make contact with the paper. This defect could have occurred from a bent tab such that it made a small hole every several tabs. Prior to a lot? S release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan. Inspectors routinely examine a statistical sample both physically and visually. Specifically, pads are visually inspected for holes or tears. The lot met all defined acceptance requirements and was released. The trend for this complaint is low. The machine currently does not have any tabs misaligned that could cause this issue. No formal correction actions/preventative actions are required at this time. This information will be utilized for trending purposes to determine the need for additional corrective actions.
Patient Sequence No: 1, Text Type: N, H10
[67113651]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an eye gauze pad. The customer reports a tear in the packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2017-00023 |
| MDR Report Key | 6308965 |
| Date Received | 2017-02-07 |
| Date of Report | 2016-02-04 |
| Date Mfgr Received | 2016-02-04 |
| Date Added to Maude | 2017-02-07 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN ROAD |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 03201 EYE PADS |
| Generic Name | EYE GAUZE PAD |
| Product Code | HMP |
| Date Received | 2017-02-07 |
| Model Number | 03201 |
| Catalog Number | 03201 |
| Lot Number | 15M171162 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |