MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 3-1/2X4 STR 10S 32 PLY; GAUZE SPONGE

Model Number	7320
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 09/12/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze pad.The customer reports the sponges contain loose fibers.
Additional Manufacturer Narrative
An investigation of the reported condition was being performed.Sixty-six samples were returned by the customer for evaluation.After performing a visual inspection, the reported condition was confirmed.The corner of the gauze had loose fibers fraying out.It looks as though the yarn has been pulled out on the corner.The returned product does not meet the quality standards.A product analysis could confirm that the issue contributed to the reportable event.The most probable root indicates that the threads were most likely snagged on a burr on the cross fold paddle and/or fingers.Preventive maintenance for the autobander equipment does require the inspection of the paddle and fingers of the cross fold for overall condition.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.As a corrective action, a visual inspection is being performed to inspect for loose threads during production.An existing formal investigation action is not being taken to address this issue.This information will be utilized for trending purposes to determine the need for additional corrective actions.Since the production of this material, the number of in-process checks for this product has been increased in hopes to catch this defect.Containment sampling plans has been updated as per corrective action and preventive action (capa) to increase the visual and functional inspections during production to ensure compliance to requirements.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISTEC SPG 3-1/2X4 STR 10S 32 PLY
• Common Device Name: GAUZE SPONGE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• MDR Report Key: 5943439
• Report Number: 1018120-2016-00123
• Device Sequence Number: 698691
• Product Code: GDY
• UDI-Device Identifier: 00884527017235
• UDI-Public: 0884527017235
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/08/2016

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: Other
• Device Model Number: 7320
• Device Catalogue Number: 7320
• Device Lot Number: 16E131962
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 09/12/2016
• Supplement Report FDA Received Date: 10/11/2017
• Patient Sequence Number: 1