MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE LEFT HEART CATH SH 36634 (LHSNA)654; GENERAL SURGERY TRAY (KIT)

Model Number	SANHDLHSNB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot#20190628-23-sh was manufactured on 08 jul 2019.Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.207g / 10 pieces.No sample available for investigation, only photo of blue lint found on the sample was provided.According to the supplier, the or towel is made of cotton, so cotton fiber is born and inevitable.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions 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, the supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product¿s transfer.From the investigation, there was 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 action taken at this time, but the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported that during a left heart catheterization with percutaneous coronary intervention, blue lint from the blue or towels pwtb04-stm from the left heart catheterization pack/ sanhdlhsnb was found in the irrigation bowl after the doctor wiped his hands.The towels were used on top of the drape and to wipe the surgeon's hands.The lint was found prior to reaching the patient.Per the customer, there was no injury to the patient.No patient demographics were provided.Although there was no injury, cardinal health is proactively filing an mdr report for potential risk.

• Brand Name: LEFT HEART CATH SH 36634 (LHSNA)654
• 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: 9457592
• Report Number: 1423537-2019-00378
• Device Sequence Number: 2667690
• Product Code: LRO
• UDI-Device Identifier: 10887488707204
• UDI-Public: 10887488707204
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: SANHDLHSNB
• Device Catalogue Number: SANHDLHSNB
• Device Lot Number: 293351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1