MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC HEART CATH PACK (HCNSB)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	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review did not indicate any exception that could lead to the reported incident.The average linting data is 0.166g/10pcs.The sample was not available at the time of investigation.Photos were provided and blue lint was found on the gloves.According to our 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: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10pieces).D.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.The investigation results revealed no abnormal situation occurred during production or device history review; therefore, the root cause was not determine.The complaint information was shared with the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported the blue towels (pwtb04-stm) in their heart cath pack (san21hcnsc ) were shedding during intravascular ultrasound(ivus) procedure.Reportedly, dr.Dupont found some of the shredded fibers on the catheter and patient.No known adverse impacts to patient.No patient demographics or other information provided.

• Brand Name: HEART CATH PACK (HCNSB)177
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 3651 birchwood drive; 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14885444
• Report Number: 1423537-2022-00796
• Device Sequence Number: 12027522
• Product Code: OEQ
• UDI-Device Identifier: 10888439824247
• UDI-Public: 10888439824247
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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: 787273
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown