MAUDE Adverse Event Report: COVIDIEN CURITY SPG GZ 4X4-12 STR 10'S; GAUZE

Model Number	6939
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 12/12/2016.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 an issue occurred with gauze.The customer reports there is a lot of lint on the gauze and in the package.They can not have lint in their or areas.The product was not unfolded or unrolled.The customer never used the product because when they opened it and examined it there was a lot of lint.
Additional Manufacturer Narrative
An investigation of the reported condition was confirmed.One opened sample and four unopened sample was returned for evaluation.The sample was removed and shaken to find short fibers within the fold which fell from the sponge.The reported condition is confirmed.The returned product did not meet quality release specifications.Product analysis confirmed that the issue did contribute to the reportable event.The most likely root cause indicates that during the slitting of the gauze into slit widths, the pinking blades may create short fibers which the vacuum system picks up.If the vacuum is not set strong enough, then the fibers may not be picked up.Product is meant to be used as produced without unfolding.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.Specifically, a visual inspection is performed to inspect for linting during production.A corrective action and preventive action was being implemented and is currently awaiting for the effectiveness check.This information will be utilized for trending purposes to determine the need for additional corrective actions.Containment for the reported condition was performed as part of the aforementioned capa.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports there is a lot of lint on the gauze and in the package.They can not have lint in their or areas.The product was not unfolded or unrolled.The customer never used the product because when they opened it and examined it there was a lot of lint.

• Brand Name: CURITY SPG GZ 4X4-12 STR 10'S
• Common Device Name: GAUZE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• MDR Report Key: 6165893
• Report Number: 1018120-2016-00178
• Device Sequence Number: 13630844
• Product Code: GDY
• UDI-Device Identifier: 10884521059320
• UDI-Public: 0110884521059320
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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: 6939
• Device Catalogue Number: 6939
• Device Lot Number: 16J002862
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1