MAUDE Adverse Event Report: COVIDIEN DERMACEA X-RAY SPG 4X4 16 PLY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	441601
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the raytec gauze is fraying and leaving threads on sterile field.There was no harm to the patient.
Additional Manufacturer Narrative
According to supplier, the device history record was reviewed and indicated that the product was released accomplishing all quality standards.Samples were not received for the investigation however a photo and video was provided.The supplier stated that the gauze is made of cotton so cotton fiber is born.The supplier also stated that there is not a gauze linting test for this item however on the gauze inspection standard operation document and based on the product specifications, linting was checked on the final inspection of the folded gauze.Linting was not found on the outside surfaces of the finished gauze during the inspection.In the finished gauze inspection, the supplier fully checks each piece of gauze.Please note that this product is disposable and single use only.The product should not be reused.Also, when using the gauze, the gauze must be folded at all times; the gauze should not be opened or unfolded during use.It should be noted that the supplier did make an improvement to their cutting method and machinery in 2018 for product quality optimization to reduce the linting caused by cutting as much as possible.The reported lot from this complaint was manufactured in 2016 using the old cutting method and machinery before the improvement.Based on the clinical evaluation and risk management review, gauze product safety has been approved.Based on all available information at this time, the root cause could not be determined as no abnormities were found during the investigation.The supplier will continue to monitor the trends of this kind of issue.

• Brand Name: DERMACEA X-RAY SPG 4X4 16 PLY
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10895364
• Report Number: 1282497-2020-09659
• Device Sequence Number: 3254462
• Product Code: GDY
• UDI-Device Identifier: 10884527021239
• UDI-Public: 10884527021239
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 441601
• Device Catalogue Number: 441601
• Device Lot Number: 17052003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1