MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-28 for VISTEC SPG 4X8 NON ST 10S 12PLY 7462 manufactured by Covidien.
[56339066]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[56339068]
The plant determined during the sample analysis that the product was linting while shaking the gauze during the investigation that was completed on (b)(6) 2016 therefore this event becomes reportable.
Patient Sequence No: 1, Text Type: D, B5
[56368376]
The device history record (dhr) for lot 15k124762 indicates that there were no defects detected in the 80 samples inspected that went into this lot. A bundle of vistec element sponges with embossing identification d and package lidding was sent for evaluation. A visual examination did not show any noticeable fibers; however, when the gauze bundles were slightly shaken the short fibers fell from the sponge. The reported condition is confirmed. The root cause for the linting is that when the gauze is slit into assigned widths using the pickney blades short fibers are created. 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: develop a process to measure the amount of short fibers per sponge. Install a system to signify if the vacuum is working on the tenter and is at the on position. Increase the amount of suction on the tenter vacuums. 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 | 1018120-2016-00144 |
| MDR Report Key | 5983343 |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-28 |
| Date Mfgr Received | 2016-09-28 |
| Date Added to Maude | 2016-09-28 |
| 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 4X8 NON ST 10S 12PLY |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-09-28 |
| Model Number | 7462 |
| Catalog Number | 7462 |
| Lot Number | 16A193562 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2016-09-28 |