MAUDE Adverse Event Report: SC003 SC-FORT MILL CARDIAC CATH (CCOME)751; GENERAL SURGERY TRAY (KIT)

Model Number	SAN6BCCOMF
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the or towels (b)(4)from the cardiac catheterization kit/ (b)(4) were shedding fibers onto the wires before entering the patient¿s body and in the rinse bowl.The procedure performed was a cardiac left heart catheterization with possibility of stenting.There was no injury or delay.No patient demographics were provided.Based on supplier investigation, the device history record could not be reviewed as a lot number was not provided.No sample was provided for evaluation, only a photo showing cotton lint to twine on the medical wire and rinsed on gloves.The supplier checked retained sample.The average linting data was 0.173g / 10 pieces and within limits (=0.38g/10 pieces).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.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 the or towels (b)(4) from the cardiac catheterization pack/ (b)(4) were shedding fibers onto the wires before entering the patient¿s body and in the rinse bowl.The procedure performed was a cardiac left heart catheterization with possibility of stenting.There was no injury or delay.No patient demographics were provided.

• Brand Name: CARDIAC CATH (CCOME)751
• 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: 8674345
• Report Number: 1423537-2019-00321
• Device Sequence Number: 1808152
• Product Code: LRO
• UDI-Device Identifier: 10887488635866
• UDI-Public: 10887488635866
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/06/2019

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: SAN6BCCOMF
• Device Catalogue Number: SAN6BCCOMF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/06/2019
• 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