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.
[67112706]
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 there were no issues. 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. The oee sheet for the line on this day shows no unusual downtime or event that could cause this issue. A review of the machine setup was conducted and all machine parameters were set within validated specifications. All in process checks were conducted and found no issues. 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. The defect is confirmed. The customer sent back 7 boxes of samples that were unopened and unused on 10/20/2016. After a 100% inspection, no packages with the small tears pictured in the photos taken by the customer were found. 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 issue could have occurred from a bent tab such that it made a small hole every several tabs. A formal corrective and preventative action has been opened for this issue. It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing activities. In addition, as a preventive action for manufacturing site operations, a monthly complaints report is sent to focus factory personnel, summarizing the latest events reported by the customer.
Patient Sequence No: 1, Text Type: N, H10
[67112707]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an eye gauze pad. The customer states there are holes/tears in the peel pouch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2017-00024 |
| MDR Report Key | 6309141 |
| Date Received | 2017-02-07 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-06-01 |
| 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 | Y |
| 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 |