MAUDE Adverse Event Report: COVIDIEN SPNG,GAUZE,4 IN X 4 IN,16 PLY,; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7148
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the product was covered with particulates.Additional information received from the customer stated that the particulates found in the gauze are from the x-ray detectable strip.The issue was notice before use.No patient involved.
Additional Manufacturer Narrative
H 3: evaluation summary a device history record (dhr) review was completed for the reported lot number.There were no manufacturing issues related to the complaint issued for this lot.A photo was submitted with the complaint.It could not be determined what exactly the contamination on the sponge was from the photo.By the look of the blue specks, it could be pieces of the element.Samples of sponges were returned for evaluation.After reviewing the samples received, it is confirmed to be pieces of element.This complaint is considered confirmed.Root cause of the issue could be if the element piping is misaligned so that the element does not carry over far enough to contact the pressure roller, the element may burn on the heated roller.If excessive amounts of the element material are threaded to the gauze, the element may contact the heated roller and the heat will cause the element to break apart, leaving bits of element within the sponge.Corrective action for the element adhering to the heated roller is that the roller must be manually cleaned to remove the element.Burned element may get on the gauze during this cleaning process.If the burnt element residue is not removed after the roller is cleaned, burnt element may come off of the roller(s) and transfer to the gauze.Inspections are performed based on a statistical sampling both physically and visually.Specifically, operators are required to inspect samples at the beginning, middle and end of lots.These checks are noted on the device history record.Employees involved with the process of producing the product have been made aware of the issue and have been alerted to watch for any type of contamination.This complaint will be used for tracking and trending purposes.

• Brand Name: SPNG,GAUZE,4 IN X 4 IN,16 PLY,
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 9194920
• Report Number: 1018120-2019-00383
• Device Sequence Number: 14103279
• Product Code: GDY
• UDI-Device Identifier: 10884527016969
• UDI-Public: 10884527016969
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 19G177862
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1