MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 4X8 NON ST 10S 12PLY; GAUZE SPONGE

Model Number 7462

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/10/2016.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 reports that the gauze had 11ea in a pack instead of 10ea in the pack.

Manufacturer Narrative

The device history record (dhr) for lot 15l184562 indicates that there were no defects found in the (b)(4) samples inspected from the lot.There were no samples submitted with this complaint therefore the reported condition could not be confirmed.The complaint shall be reopened if a sample is received.The exact root cause of the reported condition could not be determined without an actual sample to examine.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 scale system is set up to detect miscounts during the autobander process.The lot met all defined acceptance requirements and was released.A formal corrective and preventative action (capa) has been opened to address similar issues described in the compliant.During this capa, the off line banding equipment was discontinued.A reversal of the autobander trays was performed to tighten the bands.Implementation of this capa will optimize the autobander process in which a failure mode and effect analysis will be updated to include this complaint issue and to identify the occurrence.This capa is currently in the investigation stage.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 4X8 NON ST 10S 12PLY
• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5492617
• MDR Text Key: 40414625
• Report Number: 1018120-2016-00036
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 15L184562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1