MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC STERILE SINGLE BASIN GENERAL SURGERY TRAY BLUE DISPOSABLE TOWEL

Model Number SUT13SBMGA

Device Problems Material Disintegration (1177); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Event Description

Md regarding significant concerns regarding lint/thread/debris shedding from the new blue sterile towels.The new blue towels leave a lot of debris.This is a significant stroke/embolic risk during neuro endovascular procedures.We have since tested the following cardinal items: two packs of disposable towels with different lot numbers 180525-16-sh/180322-16-sh (cat# 28700-004, bar code: ((b)(4)).Blue disposable towel from single basin custom pack lot # 963391( cat # sut13sbmga, bar code: ((b)(4)).Blue disposable towel from major basin custom pack lot # 980587 (cat # sut13bmmga bar code: ((b)(4)).With and without agitation.Soaking in sterile saline.Soaking in sterile water.We found lint/debris in every test, the most significant amount of debris we were able to visualize was in the towel that was soaking.The cardinal reps were in house and we notified them and sent them the test results for internal qa review.Tested another manufacturer green rf or towels.Again tested with and without agitation, dry and then soaking in sterile saline.Debris was present , appeared less than the above cardinal items.Manufacturer response for general surgery tray, cardinal health (per site reporter).Email from @cardinalhealth.Com.Subject: re: linting with or towels.".We have submitted a product quality report and have marked urgent so that it is prioritized.I am also working to put together a few alternative options for you to try.More to come asap.".

• Brand Name: STERILE SINGLE BASIN GENERAL SURGERY TRAY BLUE DISPOSABLE TOWEL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8050544
• MDR Text Key: 126572138
• Report Number: 8050544
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488644226
• UDI-Public: (01)10887488644226
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SUT13SBMGA
• Device Catalogue Number: SUT13SBMGA
• Device Lot Number: 963391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA