MAUDE Adverse Event Report: COVIDIEN 7320 SPG VISTEC 4X3-1/2 STR-10; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7320

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Information (3190)

Event Date 11/26/2018

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

The customer states the package had 8 raytecs instead of 10.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.18h028262 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.For sterilized products, the dhr and the sterilization documents undergo further review prior to release.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 reported customer complaint could not be confirmed.A root cause could not be determined.A capa is currently open to investigate and address the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: 7320 SPG VISTEC 4X3-1/2 STR-10
• 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: 8147143
• MDR Text Key: 129897817
• Report Number: 1018120-2018-00314
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7320
• Device Catalogue Number: 7320
• Device Lot Number: 18H028262
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1