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

Model Number 7317

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a gauze sponge.The customer states the product was fraying and strings were falling off while in the patient.The doctor had to pick each strand out of the patient during surgery.

Manufacturer Narrative

The device history record (dhr) for lot 16b071662 indicates that (b)(4) cases were produced on (b)(6) 2016.No issues were found in the samples inspected from the lot.There were (b)(4) sealed packages containing (b)(4) banded vistec sponges per package that was sent to the manufacturing facility for evaluation.Visual examination did not show any noticeable fibers; however, when the gauze bundles were slightly shaken the short fibers fell from the sponge.The reported condition is confirmed.The root cause for the linting is that when the gauze is slit into assigned widths, short fibers are created.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, 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 investigation was opened because of linting/short fibers, and is currently in open investigation.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.

• 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 30906
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfild, MA 02048 ; 5084524811
• MDR Report Key: 5535967
• MDR Text Key: 41765531
• Report Number: 1018120-2016-00050
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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
• Device Operator: Health Professional
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 16B071662
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1