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

Model Number 7148

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/06/2015.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 states that there was 11 in the pack instead of 10.

Manufacturer Narrative

The device history record was reviewed for lot # 15d147762x produced on 04/21/2015 and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections were within specifications during the production process.A root cause for the reported condition is attributed to the manufacturing process when a sponge was accidently removed from a stack of sponges.This process could lead to a stack that should contain ten sponges to have shortage of sponges within the stack.This can potentially occur when handling the product, during the packaging stage of processing.A formal corrective and preventative action (capa) has been opened to address the issue described in the compliant.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: 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: 5131405
• MDR Text Key: 27950406
• Report Number: 1018120-2015-00017
• 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: Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• 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: 15D147762X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1