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

Model Number 7462

Device Problems Break (1069); Material Frayed (1262); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7-13-2018.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 x-ray sponges are frayed and falling apart.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reported x-ray sponges are frayed and falling apart.¿ a review of the device history record (dhr) for lot no.17l235162 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.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 inspection of the packages.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 comprehens ive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7685942
• MDR Text Key: 114279659
• Report Number: 1018120-2018-00131
• 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,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• 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: 17L235162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Patient Sequence Number: 1