MAUDE Adverse Event Report: AUGUSTA VISTEC SPG 4X4 NON ST 10S 16PLY; GAUZE SPONGE

Model Number 7148

Device Problem Component Missing (2306)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 2015.An investigation is currently under way.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a gauze sponge.The customer reports that the bundle was missing gauze; it was miscounted.

Manufacturer Narrative

Six banded samples were received for evaluation.Samples should be banded into groups of 10 individual sponges for one band.The device history record (dhr) was reviewed for lot # 15d229162x and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A root cause for the reported condition cannot be specifically identified.A potential root cause is during the handling of the product an operator could have removed a sponge from the bundle of 10.Another is a sponge could have become dislodged from the bundle of 10 during further handling.Scales are in place to check to every stack of sponges prior to the product being packaged.These scales are challenged for accuracy.A formal corrective and preventative action (capa) has been opened and subsequently closed to address similar issues described in the compliant.From the lot number it can be determined that this product was produced prior to the implementation of the actions taken in the capa.This issue will be reviewed during the monthly report out for the factory.No further corrective action is required at this time.No changes to the quality control sampling plans are deemed necessary.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for trending purposes and reviewed with plant management.

• Brand Name: VISTEC SPG 4X4 NON ST 10S 16PLY
• Type of Device: GAUZE SPONGE
• Manufacturer (Section D): AUGUSTA; 1430 marvin griffin road; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5266928
• MDR Text Key: 32941876
• Report Number: 1018120-2015-00040
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 15D229162X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1