MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK ORMC (CCORB)473; GENERAL SURGERY TRAY (KIT)

Model Number	SANOCCCORC
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
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
The customer reported linting of the blue, non-x-ray, cotton or towel pwtb04-stm from the cardiac catheterization pack/ sanocccorc.The procedure performed was an angioplasty.Upon exiting the coronary artery, lint was found to be sticking to the balloon.The lint was removed from the balloon at that time.No injury was reported.There was no delay in patient care as the towels were then removed from the field and a separate pack of or towels were dropped onto the field for use.The event date of the incident was unknown by the customer.No patient demographics were provided after numerous attempts to obtain.Although there was no injury, cardinal health is proactively filing a medwatch report for potential risk to the patient.
Additional Manufacturer Narrative
Mdr follow-up report being filed as investigation results available for the linting of the blue, non-x-ray, cotton or towel pwtb04-stm from the cardiac catheterization pack/ sanocccorc.Based on supplier investigation, device history record could not able to be reviewed as lot number provided was incorrect.No sample returned for investigation.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: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).D.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 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.

• Brand Name: CARDIAC CATH PACK ORMC (CCORB)473
• 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: 9433164
• Report Number: 1423537-2019-00377
• Device Sequence Number: 2928436
• Product Code: LRO
• UDI-Device Identifier: 10887488743615
• UDI-Public: 10887488743615
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: SANOCCCORC
• Device Catalogue Number: SANOCCCORC
• Device Lot Number: 281288
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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