MAUDE Adverse Event Report: COVIDIEN 7462 VISTEC SPG 8X4 12P T-10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7462

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reports there was nine gauze in the pack instead of ten.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.17l235462 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.Zero issues were found during the inspection of the packages.All device history records (dhrs) are reviewed by the shift manager and quality assurance prior to release.For sterilized products, the dhr and the sterilization documents undergo further review prior to release to the distribution center.Prior to a lot¿s release, the lots must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.The lots met all defined acceptance requirements and was released.There were no manufacturing related issues related to the complaint issued for this lot.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The complaint file contains insufficient information to determine a specific root cause.The reported customer complaint is not confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: 7462 VISTEC SPG 8X4 12P T-10'S
• 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: 7978896
• MDR Text Key: 124136635
• Report Number: 1018120-2018-00308
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 17L235462
• Date Manufacturer Received: 09/19/2018
• Patient Sequence Number: 1