MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-20 for CURITY SPG GZ 4X4 STERILE 3033 manufactured by Augusta.
[55583169]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[55583170]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze pad. The customer reports sterile gauze sponge package was opened in the or. The gauze had a gross amount of foreign body matter on it. Based on the investigation, the complaint is now reportable. The original complaint was reported as contamination however, after the sample analysis, it was determined that the foreign particle was lint. Decision tree has been updated and 3500a completed on 9/20/2016.
Patient Sequence No: 1, Text Type: D, B5
[55584835]
The device history record (dhr) for lot 16d106762 indicates that there were no defects found in 80 samples per machine inspected from the lot. There was one open package containing two gauze sponges returned with this complaint. Upon visual examination, the folded gauze inside the package contained a large piece of lint inside the fold. The reported condition is confirmed. The returned product did not meet quality release specifications. As gauze is a fibrous material, it produces lint. This lint may have built up on the cross bars of the machine and went unnoticed. Then because of vibration of the machine fallen in during the converting process. 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. Part of the in process testing is a visual examination for contamination per statistical sampling plan for 80 samples per lot per machine. The returned product t(s), would not meet quality control release specifications in its current condition. A formal corrective and preventative action (capa) is currently in open investigation to improve and align the cleaning program within the quality system. This information will be utilized for trending purposes to determine the need for additional corrective actions. The production department will be notified of this incident with a copy of this complaint response. Currently the equipment is blown down to remove lint and dirt weekly. A deeper cleaning is performed once a month to reduce excessive lint build up.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2016-00125 |
| MDR Report Key | 5964119 |
| Date Received | 2016-09-20 |
| Date of Report | 2016-09-20 |
| Date Mfgr Received | 2016-09-20 |
| Date Added to Maude | 2016-09-20 |
| 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 STREET |
| 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 30913 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30913 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY SPG GZ 4X4 STERILE |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-09-20 |
| Model Number | 3033 |
| Catalog Number | 3033 |
| Lot Number | 16D106762 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AUGUSTA |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-20 |