MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 4X4 STR 10S 16 PLY; GAUZE SPONGE

Model Number 7317

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/17/2016.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on 05/13/2016 that a customer had an issue with a gauze sponge.The customer states the dressings are shredding in the field.

Manufacturer Narrative

The device history record (dhr) for lot 16b165062 indicates that there were no defects found in 64 samples inspected from the lot.One folded balled up sponge with package lidding was received at the (b)(4) facility for evaluation.Upon visual examination there was no presence of loose fibers found.Sponge was shaken slightly and no noticed fibers fell from the sponge.A photo was attached to the complaint but linting could not be distinguished from the photo.The potential root cause for linting is that when the gauze is slit into assigned widths the blades create short fibers.A vacuum system connected to the slitting process should pull the fibers from the slits.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 for contamination is performed during each inspection.The lot met all defined acceptance requirements and was released.A formal corrective and preventative action (capa) was opened to address the issue off linting and short fibers and is currently in open investigation phase.The corrective action plan for this capa is to: develop a process to measure the amount of short fibers per sponge.Install a system to signify if the vacuum is working on the tenter and is at the on position.Increase the amount of suction on the tenter vacuums.Create a system to make sure all knife assemblies in process described are aligned properly before the cutting process.This information will be utilized for trending purposes to determine the need for additional corrective actions.The production department will be notified of this incident with a copy of this complaint response.

• Brand Name: VISTEC SPG 4X4 STR 10S 16 PLY
• Type of Device: GAUZE SPONGE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road; augusta GA 30913
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5660743
• MDR Text Key: 46571724
• Report Number: 1018120-2016-00075
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 16B165062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1