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

Model Number 7148

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

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7-10-2018.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

Customer reported the gauze is shredding.

Manufacturer Narrative

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

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿customer reported the gauze is shredding.¿ a review of the device history record (dhr) for lot no.17k182162 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.A bag of bloody sponges was returned for evaluation.The bag was not opened due to contamination risk.During visual examination, it was difficult to observe that the sponges were falling apart.The reason sponges may fall apart is due to the tinsel strength of the woven material being weak.This can occur during production when the material is pulled during the cutting process.The material can break.Inspectors routinely examine a statistical sample both physically and visually.The lots must be deemed acceptable by passing inspections that are based on a valid sampling plan.The reported customer complaint is not confirmed.A probable cause for the issue reported is 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: 7681970
• MDR Text Key: 114045525
• Report Number: 1018120-2018-00127
• 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: 10/05/2018

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: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 17K182162
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 07/23/2018; 08/08/2018
• Supplement Dates FDA Received: 08/29/2018; 10/04/2018
• Patient Sequence Number: 1