MAUDE Adverse Event Report: COVIDIEN VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7462

Device Problem Material Separation (1562)

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

Event Date 06/04/2018

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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported the blue thread separates from the gauze and there is a risk that it stays in the patient.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reported the blue thread separates from the gauze and there is a risk that it stays in the patient.¿ the device history record (dhr) for the reported lot number 18a205862 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.A sample was returned for evaluation.Visual examination of all ten (10) sponges observed they were in an unfolded state.The finished product is produced in a folded state.From the unfolded state, the element is not loose on the sponges.From the unfolded state it is unconfirmed that the element is loose.The autobanding equipment that is used adds two x-ray detectable elements.These elements are heat bounded to the gauze, ensuring the element adheres to the gauze.The element tension, heater iron temperature, bonding wheel pressure, feed roll pressure, sponge machine speed, bonding wheel weight and bonding wheel rubber height are noted on the device history record (dhr) that all were within acceptable parameters.This complaint is not confirmed with the sample.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISTEC
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 7628954
• MDR Text Key: 111997359
• Report Number: 1018120-2018-00105
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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: Health Professional
• Device Model Number: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 18A215862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 09/06/2018
• Patient Sequence Number: 1