MAUDE Adverse Event Report: COVIDIEN 6939 SPG GZ 4X4-12 STR 10'S; FIBER, MEDICAL, ABSORBENT

Model Number	6939
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Physical samples were not received for the investigation as the product has been discarded.Four photos were provided for evaluation.A visual analysis was completed, and the reported issue was confirmed.It is clear from the photos that the gauze had loose fibers fraying out.Fraying is a condition whereby the product exhibits excess fibers separating from the product typically around the outer edges or areas where the product has been cut or slit.This is where the gauze tensile strength is weak in that part of the construction of the material.Sampling plans are in place for production at beginning, middle and ending of the lots for defects, fraying is one of the checks that is done on every lot.Without a sample for evaluation a root cause could not be determined, therefore appropriate corrective action to address the issue cannot be implemented.A remediation team is being put together to review this complaint.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.
Event or Problem Description
The customer reported that the gauze was fraying.Additional information provided by the customer stated that they use the gauze to wipe multiple wires/catheters that are entering the patient through a sheath during a cerebral angiogram.

• Brand Name: 6939 SPG GZ 4X4-12 STR 10'S
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 9843296
• Report Number: 1018120-2020-00408
• Device Sequence Number: 2856076
• Product Code: FRL
• UDI-Device Identifier: 10884521059320
• UDI-Public: 10884521059320
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 03/17/2020

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: 6939
• Device Catalogue Number: 6939
• Device Lot Number: 20A128762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/17/2020
• Patient Sequence Number: 1