MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH PACK (CPJSD)115; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN11CPJSE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.The average linting data is 0.196g/10pcs.There was no sample available for investigation 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 as follows: suction machines have been installed in the grey cloth rolling process, dyeing process, and cutting process, the suction process was added before product's final folding, and workers process 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 lint from being stuck onto the product 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 informed to the relevant sectors for their awareness.There is no action taken at this time, supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer has reported an abundance of lint from the blue cotton or towels, pwtb04-stm, from the cath pack, san11cpjse.The lint is coming off during surgical procedures and attaching to the wires.There has been no injury reported.No further information, clinical data, or patient demographics were provided when requested.

• Brand Name: CATH PACK (CPJSD)115
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• 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: 14046337
• Report Number: 1423537-2022-00744
• Device Sequence Number: 14679393
• Product Code: OEQ
• UDI-Device Identifier: 10888439935462
• UDI-Public: 10888439935462
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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 Expiration Date: 05/01/2023
• Device Model Number: SAN11CPJSE
• Device Catalogue Number: SAN11CPJSE
• Device Lot Number: 759484
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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 Sex: Unknown