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

Model Number 7317

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

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 reported that the x-ray gauze sponges are of poor quality, they are frayed on the sides and fall apart.There were no patient injuries reported.

Manufacturer Narrative

The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were no manufacturing related issues related to the complaint issued for this lot.The training records for the manufacturing associates involved in the event indicate they were up to date with all training pertinent to the manufacture of this product.Also, there was no indication of maintenance documented in the maintenance log for the dates of production for this affected lot.There were few samples and pictures provided for the evaluation.The investigation team performed brainstorming exercises and gemba activities of the process flow.Upon analysis, the reported condition is confirmed.The root cause of the frayed edges could be due to the condition of the raw material (salvage edge) received from the camden operations, that was utilized to manufacture of this product.A quality alert was issued to address the issue and containment notification has been sent to the operators in the vistec room.Also, the employees involved with the process to manufacture this product have been made aware of the issue.A corrective action is not applicable at this time.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• 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: 10442539
• MDR Text Key: 204026491
• Report Number: 1018120-2020-00423
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• 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: 11/04/2020

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: No Information
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 20B106062
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 11/04/2020
• Patient Sequence Number: 1