MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (CCMHE)623; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SANHFCCMHF
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record revealed lot number 20200819-23-sh was finished on september 30th, 2020.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.168g / 10 pieces.No sample was available at the time of investigation, but photo of the lint found in gloves was provided.According to the supplier, operating room 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: 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.(b)(4).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 taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported operating room towels (pwtb04-stm ) are linting on instruments and came in the air when pack(sanhfccmhf) was opened before peripheral procedure.The towels were removed upon finding lint and was discarded.There were no delays or injury noted.No patient demographics provided.

• Brand Name: CARDIAC CATH PACK (CCMHE)623
• 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
• MDR Report Key: 11606330
• Report Number: 1423537-2021-00619
• Device Sequence Number: 4205853
• Product Code: OEQ
• UDI-Device Identifier: 10888439826364
• UDI-Public: 10888439826364
• 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): 04/01/2021

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: SANHFCCMHF
• Device Catalogue Number: SANHFCCMHF
• Device Lot Number: 537874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/01/2021
• Patient Sequence Number: 1