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 the sterile field.There was no harm to the patient.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.According to the dhr records, this batch of products was produced without linting abnormality.No physical sample was provided for the evaluation.However, a picture and a video were provided for the investigation.The gauze is made of cotton, so cotton fiber is born.On gauze inspection standard operation document based on product specification, linting was checked on final inspection for final folded gauze.The linting is not allowed on the outside surfaces of finished gauze during inspection.In the finished gauze inspection, the supplier will fully check 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.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.By ce.Based on all of the available information, the definite root cause of the reported issue could not be determined.A corrective action is not applicable at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• 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: 10895318
• Report Number: 1282497-2020-09660
• Device Sequence Number: 11576823
• 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: 17063004
• 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