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 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 6-14-2018.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported x-ray gauze shredded and causing lint concerns.

Manufacturer Narrative

Submission date: (b)(6) 2018.An investigation was performed for the reported customer complaint: ¿the customer reported x-ray gauze shredded and causing lint concerns.¿ a review of the device history record (dhr) for lot no.17k182062 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.There was one (1) sponge returned for evaluation.The product was opened and examined for fraying.During visual examination and cross examination of the sponge, fraying was observed.The reason for fraying in the product is due to the tinsel strength of the woven material becoming weak.This can occur during production when the material is pulled during the cutting process.The material can break.The location of the tear would not easily be observed during a visual inspection in production.Inspectors routinely examine a statistical sample both physically and visually.If the material did a complete tear out, then the roll would be evaluated.The lots must be deemed acceptable by passing inspections that are based on a valid sampling plan.The reported customer complaint is confirmed.The root cause was determined to be material weakened during production process.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: 7602530
• MDR Text Key: 111148444
• Report Number: 1018120-2018-00085
• 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: 08/24/2018

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: 17K182062
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 08/24/2018
• Patient Sequence Number: 1