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

Model Number 7318

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/30/2017.A complaint of ¿the customer reports there is residue upon opening.Pieces of gauze are separating from the actual sponge and contaminating the sterile field" was received for the spg 7317 vistec 4x8 str 10x12 ply product.4 samples were received, and visual inspection has been done.A dhr review was completed for lot# 17d095362.There were no manufacturing related issues related to the complaint issued for this lot.4 samples were received, and inspection of the sample resulted in confirming the reported issue.The root cause could be during the tentering process, which occurs prior to the conversion and packaging process.A formal corrective and preventative action has been opened for this issue.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing activities.In addition, as a preventive action for manufacturing site operations, a monthly complaints report is sent to focus factory personnel, summarizing the latest events reported by the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports there is residue upon opening.Pieces of gauze are separating from the actual sponge and contaminating the sterile field.

• Brand Name: VISTEC
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7071953
• MDR Text Key: 93444608
• Report Number: 1018120-2017-05122
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2017

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: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 7318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 11/30/2017
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1