MAUDE Adverse Event Report: SC003 SC-FORT MILL HEART CATH TRAY (CCMWR)156; GENERAL SURGERY TRAY (KIT)

Model Number	SAN12CCMWS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for the blue or towels pwtb04-stma, lot #f93875 shows that the product was manufactured on 11th to 21st sep 2018.Based on the supplier¿s investigation, the device history record review did not indicate any exception that would have led to the reported incident.The supplier evaluated the retained sample.The average linting data was 0.12g/5 pieces and within limits (=0.38g/10 pieces).A sample from the customer was not provided for evaluation at this time.The or towel is made of cotton, so lint is born and inevitable.The intended use of or towel is to be used for applying medication to or absorbing small amounts of body fluids from a patient's body surface.Measures to better control and improve linting have been implemented.A suction process was added before products' final folding and operators perform this activity according to standard operation procedure requirements.In the folding process, one cloth bag protects 100 pieces of semi-finished products to avoid linting stuck onto the products during product transfer.Based on the investigation, all linting test data is within the acceptable range.There is no abnormal situation that has happened in production.Therefore, the root cause could not be determined and no further action taken.The complaint information was shared with the relevant sectors within the manufacturing facility for their awareness and we will continue to monitor for this type of incident.
Event or Problem Description
The customer reported that lint from the blue or towels pwtb03-stma from the heart catheter tray kit/ san12ccmws was found on the physician¿s hands and in the irrigation bowl during a left cardiac catheterization.The towels were used to clean equipment.There was no injury reported.

• Brand Name: HEART CATH TRAY (CCMWR)156
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8305017
• Report Number: 1423537-2019-00260
• Device Sequence Number: 1789321
• Product Code: LRO
• UDI-Device Identifier: 10887488822198
• UDI-Public: 10887488822198
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SAN12CCMWS
• Device Catalogue Number: SAN12CCMWS
• Device Lot Number: 517700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR