MAUDE Adverse Event Report: COVIDIEN 7318 SPG VISTEC 8 X 4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7318
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2021
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
Customer reports: there are particles in the gauze and the fibers break down.This is for use in the operating room.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported there were particles in the gauze and the fibers break down.The reported gauze is for use in the or.A device history record review was performed for the reported product.There were no manufacturing related issues related to the complaint issued for this lot.A photo and physical sample were received and analyzed.The investigation team performed brainstorming exercises and gemba activities of the process flow, concluding the reported product issue as confirmed and related to manufacturing.The probable cause of the debris stems from build up of burnt element on heat roller.A complaint trend analysis performed for the product family identified an increase in related complaints.An investigation has been initiated and the scope encompasses the reported lot number.Investigation of machines identified improper cleaning within the sponge folding area of the machines, thus allowing accumulated lint and other debris to fall into or on the sponges.A quality alert was issued to address containment notification to the manufacturing operators.All operators were notified and an additional employee was onboarded with the primary job function of "perform deep cleaning of all machines and document completion within the cleaning activity log at the end of every shift".In addition, heightened inspection has been implemented.This complaint will be used for tracking and trending purposes.

• Brand Name: 7318 SPG VISTEC 8 X 4 STR 10'S
• 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: 11604302
• Report Number: 1018120-2021-00439
• Device Sequence Number: 19672029
• Product Code: GDY
• UDI-Device Identifier: 00884527017006
• UDI-Public: 00884527017006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 20E049662
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1