MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH SPECIALS PACK (CSGSD)892; GENERAL SURGERY TRAY (KIT)

Model Number	SAN5CCSGSD
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for the blue non-xray towels 101625, lot #11rk01-sh showed no exception that could lead to the reported incident.The supplier checked on the retained sample.The average linting data was <0.38/10 pieces and within limits (=0.38g/10 pieces).No sample was 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 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 blue non-x-ray towels 101625 from the catheterization specials pack/ (b)(4).The procedure performed was an invasive cardiac angiogram where there was a delay mid procedure to evaluate lint seen on instruments and to make sure all instruments were clean, prior to entering the patient¿s body.There was no patient injury.No patient demographics were provided.

• Brand Name: CATH SPECIALS PACK (CSGSD)892
• 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: 8785528
• Report Number: 1423537-2019-00331
• Device Sequence Number: 19331179
• Product Code: LRO
• UDI-Device Identifier: 10888439432428
• UDI-Public: 10888439432428
• 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): 07/12/2019

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: SAN5CCSGSD
• Device Catalogue Number: SAN5CCSGSD
• Device Lot Number: 215263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/12/2019
• 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