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

Model Number 7317

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

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 blue strings are pulling out of the sponge.There was no patient harm.

Manufacturer Narrative

Section e1 has been updated to include the first and last name and email address of the initial reporter.Section e1 also contains a correction to the initial reporter's phone number (direct line).

Manufacturer Narrative

A review of the device history record yielded no discrepancies within the manufacture of the affected lot.Photographs and a physical sample were received and analyzed.The investigation team performed a gemba walk through of the process flow.The investigation yielded that the reported condition was confirmed.The most probable cause of the loose string is that the there was an element resin change and new bonding machine parameters needed to be qualified.Employees involved with the process to produce this product have been made aware of the issue and to be alert to this kind of issue to heighten awareness and avoid any future occurrence.A formal corrective/preventative action will not be initiated at this time as there is no trend of this reported issue related to this product.This complaint will be closed with no further action and will be used for 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: 11095387
• MDR Text Key: 224854337
• Report Number: 1018120-2020-00431
• 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: distributor,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

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: 20E167962
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/28/2020; 12/28/2020
• Supplement Dates FDA Received: 12/30/2020; 03/29/2021
• Patient Sequence Number: 1