MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-28 for VISTEC SPG 4X4 NON ST 10S 16PLY 7148 manufactured by Covidien.
[51368720]
Submit date: 07/28/2016. An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[51368721]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze sponge. The customer reports x-ray gauze linting.
Patient Sequence No: 1, Text Type: D, B5
[54669031]
The following is offered in response to your recent complaint submission: an investigation of the reported condition was performed at the manufacturing facility. There was no lot number provided with this complaint, therefore it was not possible to complete a review of the lot history record. There were (b)(4) bands of (b)(4) vistec element sponges returned with this complaint. No identifying packaging was sent with the samples. An acceptable quality level (aql) sample per the inspection standard requires a (b)(4) piece sample. The samples received did not shed fibers from the sponges when shaken. Based on the samples received the reported condition could not be confirmed and the exact root cause could not be determined. 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 inspections are conducted for contamination during each inspection. The lot met all defined acceptance requirements and was released. A formal corrective and preventative action (capa) was opened to address linting/short fibers and is currently in open investigation stage. 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 confirm the vacuum on the tenter is turned on and operating. Increase the amount of suction on the tenter vacuums. Create a system to make sure all knife assemblies are aligned properly before the cutting process. No containment was performed to for the reported condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2016-00106 |
| MDR Report Key | 5831484 |
| Date Received | 2016-07-28 |
| Date of Report | 2016-07-27 |
| Date Mfgr Received | 2016-09-13 |
| Date Added to Maude | 2016-07-28 |
| 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 4X4 NON ST 10S 16PLY |
| Generic Name | GAUZE SPONGE |
| Product Code | EFQ |
| Date Received | 2016-07-28 |
| Model Number | 7148 |
| Catalog Number | 7148 |
| 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 | 2016-07-28 |