MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC HEART CATH PACK (HCNSC)177; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN21HCNSC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
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.The average linting data is 0.138g/10pcs.There was no sample available for investigation.A photo that was provided by the customer showed blue lint on the gauze sponge.According to supplier, or towel is made of cotton, so cotton fiber is born.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suction machines have been installed in grey cloth rolling process, dyeing process, and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10pieces).In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.Based on the investigation, there were no abnormalities found during production of the or 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 that lint from the cotton towel, pwtb04-stm, was found on the gauze sponge from the heart catheterization pack, san21hcnsc.Product issue was found during procedure.There was an approximate delay of ten minutes.The lint was found on the equipment, wire, balloon and ivus (intravascular ultrasound) shaft, and was disposed.There was no injury reported.

• Brand Name: HEART CATH PACK (HCNSC)177
• 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: 15254511
• Report Number: 1423537-2022-00819
• Device Sequence Number: 5887299
• Product Code: OEQ
• UDI-Device Identifier: 10195594412524
• UDI-Public: 10195594412524
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/18/2022

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: SAN21HCNSC
• Device Catalogue Number: SAN21HCNSC
• Device Lot Number: 867769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/18/2022
• Date Device Manufactured: 06/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Unknown
• Patient Weight: 81 KG