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

Model Number 7462

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 6-20-2018.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 pack contained only 8 x-ray sponges instead 10.

Manufacturer Narrative

Submission date: (b)(6) 2018.An investigation was performed for the reported customer complaint: ¿the customer reported the pack contained only 8 x-ray sponges instead 10.¿ a review of the device history record (dhr) for lot no.17l043662 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.One (1) sample was received for evaluation.Visual inspection and count of the sample confirmed there were eight (8) sponges.The count for a tray should total ten (10) sponges.Potential causes of miscount may include: depending on the size of the sponges, extra movement is performed to rotate the sponges prior to banding; resulting in sponge loss or the weight of the material could have resulted in the machine banding additional sponges.A capa is currently open to investigate the reported issue.The reported customer complaint is confirmed.A root cause could not be determined.A formal capa investigation is currently in progress.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: 7621993
• MDR Text Key: 111865225
• Report Number: 1018120-2018-00100
• 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

• Date FDA Received: 06/20/2018
• 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: 17L043662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Patient Sequence Number: 1