MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HEART CATHETER PACK (HCSBC)180; GENERAL SURGERY TRAY (KIT)

Model Number	SANHFHCSBD
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot#20200220-23-sh was manufactured on 2/28/2020.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.156 g / 10 pieces.At the time of the investigation the sample had not been returned to cardinal health for investigation.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously working with cah 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 requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.The investigation revealed no abnormal situation happened in production and the linting test data were within the acceptable range.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, but the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported the pack reportedly contained towels with excess lint.Allegedly on the most recent occasion, the physician was intervening and towel lint was found on the instruments.No injury was reported.Cardinal health is filing a report for potential risk.

• Brand Name: HEART CATHETER PACK (HCSBC)180
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 10174980
• Report Number: 1423537-2020-00468
• Device Sequence Number: 2366701
• Product Code: LRO
• UDI-Device Identifier: 10888439335026
• UDI-Public: 10888439335026
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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: SANHFHCSBD
• Device Catalogue Number: SANHFHCSBD
• Device Lot Number: 424409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1