MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CUSTOM ANGIOGRAPHY (ANAVI)566; GENERAL SURGERY TRAY (KIT)

Model Number	SAN34ANAVJ
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot#20190419-23-sh was manufactured on 09th may 2019.No exception was recorded in the device history record that could lead to the reported incident.Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.161g /10 pieces.No sample was available at the time of the investigation, only a photo of linting shown on the pad was provided.According to the supplier, the or towel is made of cotton, so lint is born and inevitable.The supplier is continuously working with cardinal health to better control the linting and has implemented several measures to improve it: suction 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, one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is 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 other action taken at this time, however, our supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported that lint from the blue or towels pwtb04-stm, from the angiography kit san34anavj, was found on the endovascular wire and within the pack during an angiography.There was an insignificant delay to open a separate towel pack.There was no injury to the patient as the patient was not under anesthesia.Mdr being reported based on potential risk to the patient.No patient demographics were provided.

• Brand Name: CUSTOM ANGIOGRAPHY (ANAVI)566
• 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: 9120753
• Report Number: 1423537-2019-00349
• Device Sequence Number: 10914296
• Product Code: LRO
• UDI-Device Identifier: 10888439440225
• UDI-Public: 10888439440225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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: SAN34ANAVJ
• Device Catalogue Number: SAN34ANAVJ
• Device Lot Number: 262278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/25/2019
• 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