MAUDE Adverse Event Report: COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7317

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reports there were only 5 each of gauze sponges in the pack which should have contained 10.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.18a123662 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.Samples were provided for evaluation.Investigation resulted in the following conclusions/findings: investigation of x-ray element identified the element sticking to the bottom of the tray.The ex-ray gauze is placed into the styrene tray for packaging sterile packaging.The root cause was determined to be by a chemical reaction between styrene and pvc element.The x-ray element is made of pvc material.The pvc material is potentially interacting with the styrene tray causing the product to stick to the bottom of the tray.Standard work was updated to reflect the placement of the sponge bundle into the styrene tray.An investigation also was initiated for identifying gaps with drawings, work instructions, bom¿s, formula sheets, standardized work, and conformation of correct product selection from last validation, and agreement with worst-case product validations.A capa has been initiated and is in the implementation stages.A quality stand down was completed at the line.The miscount reported for the sponges was unable to be confirmed, as no sponges were returned with the banding tape.The report of holes in the tray is also unable to be confirmed, as water was placed in the tray and observed for any seeping through the bottom of the tray.There was not any compromise of the tray.The reported customer complaint of element sticking to the bottom of the tray is confirmed.The root cause was determined to be by a chemical reaction between styrene and pvc element.A capa has been initiated and is in the implementation stages.The reported customer complaint of sponge miscount was unable to be confirmed.A root cause was unable to be determined.The reported customer complaint of holes in the tray was not confirmed.A root cause was unable to be determined.Employees involved with the process to produce this product have been made aware of the reported event(s) and to be on alert for these types of issues.

• Brand Name: 7317 SPG VISTEC 4X4 STR 10'S
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 8375390
• MDR Text Key: 137305478
• Report Number: 1018120-2019-00338
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 18A123662
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1