MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-25 for VISTEC SPG 4X4 STR 10S 16 PLY 7317 manufactured by Covidien.
[44342445]
An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[44342446]
It was reported to covidien on (b)(6) 2016 that the customer had an issue with a gauze sponge. The customer states the tops on the containers are not peeling off completely and the sponges are tearing apart while being used in the or. When the raytec was rubbed together it was like a small snow shower / also the weave was very very loose
Patient Sequence No: 1, Text Type: D, B5
[55731192]
Submit date: 09/21/2016. The device history record (dhr) for lot 15h124962x indicates that there were no defects found in 96 retain samples inspected from the lot. There were no samples submitted with this complaint therefore the reported condition could not be confirmed. The potential root cause for linting is that when the gauze is slit into assigned widths the blades create short fibers. A vacuum system connected to the slitting process should pull the fibers from the slits. 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 visual inspection for contamination is performed during each inspection. The lot met all defined acceptance requirements and was released. A formal corrective and preventative action (capa) was opened to address the issue off linting and short fibers and is currently in open investigation phase. The corrective action plan for this capa is to: a. Develop a process to measure the amount of short fibers per sponge. B. Install a system to signify if the vacuum is working on the tenter and is at the on position. C. Increase the amount of suction on the tenter vacuums. D. Create a system to make sure all knife assemblies in process described are aligned properly before the cutting process. 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 | 1018120-2016-00063 |
| MDR Report Key | 5605059 |
| Date Received | 2016-04-25 |
| Date of Report | 2016-04-21 |
| Date Mfgr Received | 2016-09-21 |
| Date Added to Maude | 2016-04-25 |
| 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 | VISTEC SPG 4X4 STR 10S 16 PLY |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-04-25 |
| Model Number | 7317 |
| Catalog Number | 7317 |
| Lot Number | 15H124962 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-04-25 |