MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-18 for VISTEC SPG 4X4 STR 10S 16 PLY 7317 manufactured by Augusta.
[40860814]
Submit date: (b)(6) 2016. An investigation is currently underway. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[40860815]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze sponge. The customer states there were 11 sponges in the tray.
Patient Sequence No: 1, Text Type: D, B5
[44713049]
The device history record (dhr) for lot 15l131262 indicates that there were no defects found in the amount of retain samples inspected from the lot. There were no samples submitted with this complaint. The reported condition could not be confirmed. The complaint shall be reopened if a sample is received. The exact root cause of the reported condition could not be determined without an actual sample to examine. 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, a scale system is set up to detect miscounts during the autobander process. The lot met all defined acceptance requirements and was released. A formal corrective and preventative action (capa) has been opened to address similar issues described in the compliant. During this capa, the off line banding equipment was discontinued. A reversal of the autobander trays was performed to tighten the bands. Implementation of this capa will optimize the autobander process in which a failure mode and effect analysis will be updated to include this complaint issue and to identify the occurrence. This capa is currently in the investigation stage. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2016-00047 |
| MDR Report Key | 5511257 |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-14 |
| Date Mfgr Received | 2016-05-06 |
| Date Added to Maude | 2016-03-18 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| 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 | VISTEC SPG 4X4 STR 10S 16 PLY |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-03-18 |
| Model Number | 7317 |
| Catalog Number | 7317 |
| Lot Number | 15L131262 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-03-18 |