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.
[44354851]
Submit date: 04/25/2016. An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[44354852]
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 they are having an issue with the sponges 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 loose.
Patient Sequence No: 1, Text Type: D, B5
[49789198]
The device history record (dhr) for lot 16b165062 indicates that (b)(4) cases were produced on (b)(6) 2016. No issues were found in samples inspected from the lot. One case of sealed packages were received for evaluation. One bundle was shaken and excessive fibers that measured less than 0. 031 inches fell from the bundle. The linting reported condition is confirmed. (b)(4) packages were pulled from the received samples to test package performance. All samples met specifications. The difficult to open is not confirmed. (b)(4) samples were pulled for tensile strength testing of gauze; tensile strength met guidelines. The falling apart reported condition is not confirmed. Woven construction of the gauze met the specifications for 20 x 10 gauze fabric for thread count. This woven construction out of specification is not confirmed. Gauze material is a natural fibrous material in which some linting may occur; however, excessive linting should not occur. The most likely root cause is that when the material is slit after the bleaching process of the material, the blades cause short fiber slits on the outside of the roll in which the existing vacuum should pick up. It may be possible that the vacuum? S efficiency is not strong enough to pick up all the loose fibers. The exact root cause of the reported condition for falling apart, woven construction, and difficult to open could not be determined because the reported condition could not be confirmed. 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, peel tests are performed package opening function, visual testing for contamination, tensile testing is perform for falling apart, and thread counts are performed for woven construction aimed at detecting the reported condition here. The lot met all defined acceptance requirements and was released. A formal corrective and preventative action investigation was opened because of linting/short fibers, and is currently in open investigation. This information will be utilized for trending purposes to determine the need for additional corrective actions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2016-00062 |
| MDR Report Key | 5604984 |
| Date Received | 2016-04-25 |
| Date of Report | 2016-04-21 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2016-03-04 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| 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 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| 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 | 16B165062 |
| 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 | 2016-04-25 |