MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ARTERIOGRAM PACK (APMFD)922; GENERAL SURGERY TRAY (KIT)

Model Number	SAN2DAPMFD
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number f94124 was manufactured on april 08 to 11, 2019.No exception was recorded in the device history record that could lead to the reported incident.No sample was available at the time of this investigation.Photos were available, with lint found on the surface and paper.Based on the supplier¿s investigation, the linting test result was 0.118g / 5 pieces, which is within limits, =0.38g/10 pieces.From the investigation, there was no abnormal situation which had occurred during production and all linting test data was within the acceptable range.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.Cardinal health and the supplier will continue to monitor the trend of this type of incident.According to supplier, or towel is made of cotton, so lint is born and inevitable.The intended use of or towel is used for applying medication to or absorbing small amounts of body fluids from a patient's body surface.Supplier had worked with cardinal health to better control the linting and have implemented several measures to improve it: the suctions process was added before products' final folding and operators do it according to standard operation procedure requirements.The results of linting tests are within limits (=0.38g/10 pieces).C) in the folding process, supplier used one cloth bag to protect 100 pieces of semi-finished products to avoid lint from sticking onto the products during product's transfer.
Event or Problem Description
Based on information received by the customer the towel in the packs are reportedly linting.No injury to patient.

• Brand Name: ARTERIOGRAM PACK (APMFD)922
• 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: 9637564
• Report Number: 1423537-2020-00403
• Device Sequence Number: 19379479
• Product Code: LRO
• UDI-Device Identifier: 10888439436129
• UDI-Public: 10888439436129
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: SAN2DAPMFD
• Device Catalogue Number: SAN2DAPMFD
• Device Lot Number: 276601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other