MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ANGIO CATH LAB PACK DOWNTOWN (ACBMA)698; GENERAL SURGERY TRAY (KIT)

Model Number	SANHFACBMB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed as lot number was not provided.However, the supplier reviewed records in the last two years, and no abnormal situation was found.No sample was available for investigation.Photos were provided which showed lint on the glove only.According to our supplier, the or towel is made of cotton, so cotton fiber is born and inevitable.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.(=0.38g/10 pieces).In the folding process, the supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there was no abnormal situation that occurred in production.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
The customer reported that lint from the blue, non-x-ray or towels pwtb04-stm in the angiography catheterization pack/ sanhfacbmb was found on the towels and on staff¿s gloves during a cardiac catheterization.There was a delay of approximately five minutes to switch out the towels and drop new ones into the sterile field.No injury was reported.The event date was unknown by the customer.Although there was no injury, cardinal health is proactively filing a medwatch report for potential risk to the patient.

• Brand Name: ANGIO CATH LAB PACK DOWNTOWN (ACBMA)698
• 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: 9506186
• Report Number: 1423537-2019-00384
• Device Sequence Number: 3350666
• Product Code: LRO
• UDI-Device Identifier: 10888439318197
• UDI-Public: 10888439318197
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: SANHFACBMB
• Device Catalogue Number: SANHFACBMB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other