MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC CARDIAC CATH PACK (CCEDC)677; CARDIAC CATHETERIZATION KIT

Model Number	SAN46CCEDD
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record could not be verified as lot number was not provided.A sample was not received for investigation.According to our supplier, the cloth towel is single use product.It is made of cotton, so cotton fiber is born.Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions 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 (sop) 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 each stack products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation happened in production.Therefore, the root cause could not be determined.
Event or Problem Description
Customer reported that during a cardiac catheterization procedure, the cloth towels pwtb04-stm from the cardiac catheterization pack san46ccedd were linting.No adverse effect to the patient was reported.No further information was provided by the customer upon request.

• Brand Name: CARDIAC CATH PACK (CCEDC)677
• Common Device Name: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 2651 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: 15810473
• Report Number: 1423537-2022-00858
• Device Sequence Number: 5616461
• Product Code: OES
• UDI-Device Identifier: 10888439629866
• UDI-Public: 10888439629866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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: SAN46CCEDD
• Device Catalogue Number: SAN46CCEDD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown