MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-25 for VISTEC SPG 4X4 STR 10S 16 PLY 7317 manufactured by Covidien.
[54040944]
An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[54040945]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze pad. The customer states the or staff are noticing the gauze are falling apart and little pieces are falling off the gauze.
Patient Sequence No: 1, Text Type: D, B5
[57739053]
The device history record (dhr) for lot 16b071762 indicates that there were no defects detected in the 80 samples inspected that went into this lot. There were five samples in sealed packages of product code 7317 returned with this complaint. Each sealed package contained one bundle of banded vistec element sponges. When the bundle was removed from the package and slightly shaken, short fibers fell from the sponge. A review of the photos that was submitted with the complaint was performed. One photo showed the linting from an unfolded used sponge. The reported condition is confirmed. A potential root cause for the reported condition is during the cutting process fibers were loosened from the sponge. This could lead to pieces of cotton to fall from the sponge. This product is not intended to be unfolded. 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. The lot is visually inspected for linting contamination. The returned product would not meet quality specification in its current state. A formal corrective and preventative action (capa) was opened because of linting/short fibers and is currently in open investigation. 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 | 1018120-2016-00115 |
| MDR Report Key | 5904800 |
| Date Received | 2016-08-25 |
| Date of Report | 2016-08-22 |
| Date Mfgr Received | 2016-10-04 |
| Date Added to Maude | 2016-08-25 |
| 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 | 2016-08-25 |
| Model Number | 7317 |
| Catalog Number | 7317 |
| Lot Number | 16B071762 |
| 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 | 2016-08-25 |