MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH TRAY (CTSRF)602; CARDIAC CATHETERIZATION KIT

Model Number	SCVOCCTSRG
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record for lot# 20190517-23-sh was manufactured on 24th may 2019.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.162g / 10 pieces.No sample was available for investigation.According to supplier, or towel is made of cotton, so cotton fiber is born.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, 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 is no abnormal situation that has 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 supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported to cardinal health that during a pediatric cardiac catheterization, lint from the blue or towels pwtb04-stm from the cardiac catheterization pack/ scvocctsrg was found on the wires and in the saline bowl.There was no injury to the patient and no impact post-procedure.No patient demographics or event date were provided after attempts to obtain.

• Brand Name: CARDIAC CATH TRAY (CTSRF)602
• Common Device Name: CARDIAC CATHETERIZATION 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: 9808676
• Report Number: 1423537-2020-00434
• Device Sequence Number: 1800299
• Product Code: OES
• UDI-Device Identifier: 10887488768809
• UDI-Public: 10887488768809
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/09/2020

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: SCVOCCTSRG
• Device Catalogue Number: SCVOCCTSRG
• Device Lot Number: 336001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/09/2020
• 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