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

Model Number 4334

Device Problems Material Separation (1562); Noise, Audible (3273)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7-9-2018.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 reports the product is thrum and chipping.

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 reports the product is thrum and chipping.¿ a review of the device history record (dhr) for lot no.17d085662 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.Two (2) samples, sponge bundles, were received for evaluation.Visual inspection, cross-examination, and shaking of the sponges did confirm there is linting.Actions have been taken to eliminate potential linting in the process.The nonconformity of short fibers (¿linting¿) can develop from the two-step cutting process the material undergoes.One of the cutting operations occurs at the tenter and cuts the gauze to a certain width.The other occurs at the autobander machine and cuts the gauze into a square.Corrective action has been taken to install a system to signify if the vacuum is working on the tenter and it is on.Procedures have been implemented requiring operators to have vacuums on during the slitting process.Operators are required to ensure the vacuum is on and to inform maintenance if vacuums are not working.Also, the amount of suction on the tenter vacuum has been increased.Procedural update also included requirement of the slitter blades on the tenters to be inspected every shift.All blade changes are to be documented.The samples were also routed to the production floor for review and to make evident how quality impacts our customers.The reported customer complaint is confirmed.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: 7670975
• MDR Text Key: 113635387
• Report Number: 1018120-2018-00122
• 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: 4334
• Device Catalogue Number: 4334
• Device Lot Number: 17D085662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 07/20/2018; 08/08/2018
• Supplement Dates FDA Received: 08/31/2018; 10/05/2018
• Patient Sequence Number: 1