MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE FEMORAL ANGIO TRANSJUGULAR (MACCT)126; GENERAL SURGERY TRAY (KIT)

Model Number	SAN29MACCU
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported linting of white fibers on the or towels 01625 from the femoral angiography transjugular pack/ san29maccu.The procedure performed was a diagnostic cerebral angiogram where the towels were used on top of the drape to absorb procedure fluids.There was no patient injury or delay in procedure.No patient demographics or clinical data was provided.A review of the device history record did not indicate any exception that could lead to the reported incident for the or towels lot#11rl11-sh.Linting records showed the average linting results were within acceptable limits 0.38g/10 pieces.At the time of this report, the sample has not been received by the manufacturing facility for evaluation.If returned to them an investigation will be done and a follow up report will be filed.
Event or Problem Description
The customer reported linting of white fibers on the or towels 01625 from the femoral angiography transjugular pack/ san29maccu.The procedure performed was a diagnostic cerebral angiogram where the towels were used on top of the drape to absorb procedure fluids.There was no patient injury or delay in procedure.No patient demographics or clinical data was provided.

• Brand Name: FEMORAL ANGIO TRANSJUGULAR (MACCT)126
• 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: 8484784
• Report Number: 1423537-2019-00304
• Device Sequence Number: 2457643
• Product Code: LRO
• UDI-Device Identifier: 10887488737195
• UDI-Public: 10887488737195
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/04/2019

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: SAN29MACCU
• Device Catalogue Number: SAN29MACCU
• Device Lot Number: 188084
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/04/2019
• 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