MAUDE Adverse Event Report: COVIDIEN VISTEC SPG 4X4 NON ST 10S 16PLY; X-RAY DETECTABLE SPONGE

Model Number 7148

Device Problem Incomplete or Missing Packaging (2312)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be fowarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with an x-ray detectable sponge.The customer states that there is supposed to be 10 each in the pack but there were 9 each.

Manufacturer Narrative

The complaint report indicated that a returned sample was not expected and to date a sample has not been received.This complaint will be re-opened should a sample be returned in the future.As part of the manufacturing process, a device history record (dhr) is generated for the lot of product.The dhr review showed that all acceptance criteria inspections were within specifications during the production process.The root cause for the reported condition is attributed to a miscount when product is removed from the original stack of 10 sponges resulting in a shortage within the stack.A formal corrective and preventative action (capa) has been opened to address the issue described in the complaint.This lot was produced prior to the implementation of the changes made by the capa.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.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: X-RAY DETECTABLE 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: 5195084
• MDR Text Key: 30480956
• Report Number: 1018120-2015-00029
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• 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: 14K138862X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• 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