MAUDE Adverse Event Report: COVIDIEN 7148 VISTEC SPG 4X4 16P T-10S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7148

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reported strings were falling off of the gauze.The issue was discovered prior to use, during set-up for the procedure.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.18a068762 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.All device history records (dhrs) are reviewed by the shift manager and quality assurance prior to release.Inspectors routinely examine a statistical sample both physically and visually.For sterilized products, the dhr and the sterilization documents undergo further review prior to release to the distribution center.No issues were found during the inspections.There were no manufacturing issues related to the complaint issued for this lot.Five (5) samples were received for evaluation.Inspection of the samples observed an irregular fold.The reported event is confirmed.The reason for the irregular fold in the product is due to unfolded cut edges of the gauze.This can occur somewhere between production and kitting of the sponge process.The fold of the sponge has come unfolded, causing the cut edges to become visible.During the production process, the converting machine folds the sponge into the appropriate finished size after cutting the gauze.Then, the sides will be folded over by 4 inches twice, with the ends then folded into thirds.The reason for this folding is to eliminate raw edges and fraying to happen to the sponge.Sampling plans are in place for production at the beginning, middle and end of the lots for imperfections, fraying and loose threads.It is part of the quality checks that are completed for every lot.The reported customer complaint is confirmed.The root cause was determined to be an irregular fold which occurred during the production process.Employees involved with the process to produce this product have been made aware of the reported event and to be on alert for this type of issue.Additionally, samples were routed to the production floor for review with staff and to reiterate how quality impacts our customers.This complaint will be utilized for tracking and trending purposes.

• Brand Name: 7148 VISTEC SPG 4X4 16P T-10S
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 8281349
• MDR Text Key: 134307991
• Report Number: 1018120-2019-00334
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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: No Information
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 18A068762
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1