MAUDE Adverse Event Report: SC003 SC-FORT MILL CARDIAC CATH LEFT TRAY (CCCFB)667; GENERAL SURGERY TRAY (KIT)

Model Number	SANDHCCCF2
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
A review of the device history record for the blue or towels pwtb04-stma, lot#f93858 showed that the product was manufactured from the 10th to 18th aug 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 checked on the retained sample.The average linting data was 137g/5 pieces and within limits (=0.38g/10 pieces).No sample was provided for evaluation at this time.The operating room towel is made of cotton, so lint is born and inevitable.The intended use of operating room 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 was within the acceptable range.Based on the investigation, all linting test data was within the acceptable range.There was no abnormal situation that had 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 linting of the operating room towels pwtb03-stma from the cardiac catheter tray kit sandhcccf2 during a cardiac catheterization.The procedure progressed cautiously due to the need to observe for lint on wires, balloons, stents and gloves.Staff and doctor needed to change gloves during the procedure.There was no patient injury reported.No patient demographics were provided.

• Brand Name: CARDIAC CATH LEFT TRAY (CCCFB)667
• 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: 8525610
• Report Number: 1423537-2019-00309
• Device Sequence Number: 13913332
• Product Code: LRO
• UDI-Device Identifier: 10888439306071
• UDI-Public: 10888439306071
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/17/2019

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: SANDHCCCF2
• Device Catalogue Number: SANDHCCCF2
• Device Lot Number: 515256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other