MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC FEMORAL ANGIOGRAPHY (AFMMG)503; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN30AFMMG
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.There was no sample available for investigation.Supplier has implemented several measures during the manufacturing of the cotton towels.The suction process was added before products' final folding, and operators followed the standard operation procedure requirements.The linting test record found the suction results were normal which is within the acceptable range (=0.38g/10pcs).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid lint stuck onto the products during products' transfer.Based on the investigation, there were no abnormalities found during production of the or cotton towels; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.No action will be taken at this time.We will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported an abundance of lint from the cotton towel, pwtb04-stm, during an angioplasty in the catheterization laboratory using a cardinal health femoral angiography pack , san30afmmg.The doctor frequently rinses and dries his gloved hands with the towel during procedure and he sometimes places the towel on the bottom of the guidewire.The patient suffered no complication during procedure nor after.
Additional Manufacturer Narrative
This supplemental report is being filed since a sample photo was received following the submission of the initial mdr report that was submitted on 9/2/2022.Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.There was no sample available for investigation.A photo was provided on (b)(6) 2022.Visual inspection indicated linting on the non-woven fabric.Supplier has implemented several measures during the manufacturing of the cotton towels.The suction process was added before products' final folding, and operators followed the standard operation procedure requirements.The linting test record found the suction results were normal which is within the acceptable range (=0.38g/10pcs).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid lint stuck onto the products during products' transfer.Based on the investigation, there were no abnormalities found during production of the or cotton towels; therefore, the root cause could not be determined.No action will be taken at this time.We will continue to monitor trends for this type of incident.

• Brand Name: FEMORAL ANGIOGRAPHY (AFMMG)503
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 3651 birchwood dr.; waukegan IL 60085
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15351804
• Report Number: 1423537-2022-00834
• Device Sequence Number: 5998221
• Product Code: OEQ
• UDI-Device Identifier: 10887488490779
• UDI-Public: 10887488490779
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: SAN30AFMMG
• Device Catalogue Number: SAN30AFMMG
• Device Lot Number: 781653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 73 KG