MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 4X8 STR 10X 12 PLY; GAUZE SPONGE

Model Number 7318

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

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

Event Date 10/27/2015

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) 2015 that a customer had an issue with a gauze sponge.The customer states the x-ray detectable sponges have been breaking down while using in surgeries.Customer had to manually pick out as many of the frayed pieces they could.

Manufacturer Narrative

The complaint report indicated that a returned sample was expected and to date a sample has not been received.This complaint will be re-opened should a sample be returned in the future.Device history record review: the device history record (dhr) was reviewed for lot # 14m016462x 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 for the reported condition cannot be specifically identified however the potential cause could occur during the cutting process; short fibers may develop as a result of a miss cut by the blades.As a corrective action in process checks are preformed to catch quality flaws and to remove the affected product.A formal corrective and preventative action has been initiated to address the reported condition.This issue will be reviewed during the monthly report out for the factory.No further corrective action is required at this time.There are no changes to the quality control sampling plans deemed necessary.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.No formal corrective action preventive action has been created for this complaint.This complaint will be used for trending purposes and reviewed with plant management.

• Brand Name: VISTEC SPG 4X8 STR 10X 12 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 street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5221136
• MDR Text Key: 31235957
• Report Number: 1018120-2015-00033
• 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: 11/04/2015

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: Other
• Device Model Number: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 14M016462X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1