MAUDE Adverse Event Report: COV LP/LLC, AUGUSTA VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7462

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

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

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7-3-2018.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 the gauze has a defect in fabrication.For 3-4 weeks, they have terrible 4x8 gauzes in the packs.The blue thread separates from the gauze and there is a risk that it stays in the patient.

Manufacturer Narrative

Based on additional information received, the gauze is also fraying and the rfr code (b)(4) was added to this complaint.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reported the gauze has a defect in fabrication.For 3-4 weeks, they have terrible 4x8 gauzes in the packs.The blue thread separates from the gauze and there is a risk that it stays in the patient.The gauze are also fraying.¿ a review of the device history records (dhr) for reported lot number 17l080462 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.One (1) bundle containing ten (10) sponge samples was received for evaluation.Visual inspection did not observe the condition of fraying.Observation of the sponge bundle noted improper fold of the material.In the production process, the ends of the gauze are folded over before the sides are folded in the middle.Should the gauze shift, the fold will be incomplete.Creating what looks to be fray, but is actually a bad fold.The sample will be shared with personnel to further heighten awareness of this issue.The reported condition is confirmed for improper folding.A probable root cause of this condition would be attributed to the folding plates of the machine.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): COV LP/LLC, AUGUSTA; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 7659591
• MDR Text Key: 113196559
• Report Number: 1018120-2018-00114
• 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: 09/10/2018

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: 17L080462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 08/14/2018
• Supplement Dates FDA Received: 07/03/2018; 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1