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 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.

Event Description

The customer reported the product was shedding little pieces of lint onto the sterile field.They noticed it during a podiatry case when fluids were being poured, the shedding was in the water basin.No patient injury reported.

Manufacturer Narrative

H3: evaluation summary: a review of the device history record (dhr) for the reported lot number indicates that sponges were inspected for loose threads/lint and no issues were found during the inspection of the packages.All dhrs are reviewed by quality assurance prior to release.For sterilized products, the dhr and the sterilization documents undergo further review prior to release to the distribution center.Prior to a lot¿s release, the lots must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.This lot met all defined acceptance requirements and was released.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.A photo and physical sample was received and analyzed.The investigation team performed brainstorming exercises and process walk through activities of the process flow.The investigation yielded that the reported issue was confirmed.The most probable cause of the issue stems from the salvage edge/edge fold and a new set of knives needing to be installed.Trending had been done to previous product family complaints and found that a corrective and preventative action (capa) was not required at this time.The issue reported in this complaint has not reached an action trigger point.This complaint 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: 11268880
• MDR Text Key: 230064969
• Report Number: 1018120-2021-00433
• 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
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 03/30/2021
• Patient Sequence Number: 1