MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for VISTEC SPG 3-1/2X4 STR 10S 32 PLY 7320 manufactured by Covidien.
[41771593]
An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[41771594]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze sponge. The customer reports: during a hernia procedure the sponges were shredding. There was no patient injury. A new sponge was used to correct the condition the patient status is reported as good.
Patient Sequence No: 1, Text Type: D, B5
[49769618]
The device history record (dhr) for lot 15k124762 indicates that (b)(4) cases were produced on (b)(6) 2015. No issues were found in the samples inspected from the lot. A review of maintenance records (both corrective and preventive) and calibration records were reviewed and that there were no issues. All scheduled maintenance and calibration activities were completed on time. A bundle of vistec element sponges was sent to the manufacturing facility for evaluation. 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 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, 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 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. The production department will be notified of this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2016-00052 |
| MDR Report Key | 5536294 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-25 |
| Date of Event | 2016-03-22 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2015-10-20 |
| Date Added to Maude | 2016-03-30 |
| 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 3-1/2X4 STR 10S 32 PLY |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-03-30 |
| Model Number | 7320 |
| Catalog Number | 7320 |
| Lot Number | 15K124762 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-03-30 |