MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-17 for 6939 SPG GZ 4X4-12 STR 10'S manufactured by Covidien.
[183823727]
The device history record was reviewed and indicated that the product was released accomplishing all quality standards. Physical samples were not received for the investigation as the product has been discarded. Four photos were provided for evaluation. A visual analysis was completed, and the reported issue was confirmed. It is clear from the photos that the gauze had loose fibers fraying out. Fraying is a condition whereby the product exhibits excess fibers separating from the product typically around the outer edges or areas where the product has been cut or slit. This is where the gauze tensile strength is weak in that part of the construction of the material. Sampling plans are in place for production at beginning, middle and ending of the lots for defects, fraying is one of the checks that is done on every lot. Without a sample for evaluation a root cause could not be determined, therefore appropriate corrective action to address the issue cannot be implemented. A remediation team is being put together to review this complaint. Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures. This complaint will be used for qa tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
[183823728]
The customer reported that the gauze was fraying. Additional information provided by the customer stated that they use the gauze to wipe multiple wires/catheters that are entering the patient through a sheath during a cerebral angiogram.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018120-2020-00408 |
| MDR Report Key | 9843296 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-17 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN ROAD, PO B |
| 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 | 6939 SPG GZ 4X4-12 STR 10'S |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2020-03-17 |
| Model Number | 6939 |
| Catalog Number | 6939 |
| Lot Number | 20A128762 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD, PO B AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |