MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CV SET UP PACK (CVCHA)171; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCVBCCVCHB
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot# 20200707-23-sh was manufactured on 03rd aug 2020.No exception was recorded in the device history record that could lead to the reported incident.Based on the supplier investigation, the device history record (dhr) review did not indicate any exception that could lead to the reported incident.The average linting data is 0.168g / 10pieces.There are 163 occurrences reported in the past 12 months.No sample was available for investigation.According to the supplier, the operating room 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/10pieces).In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, no abnormal situation happened in production and device history record.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
Customer reported lint and fuzz on the operating room towels pwtb04-stm from the cardio vascular pack scvbccvchb during a cardiac thoracic procedure.Customer noticed linting in the air under the operating room lights when unfolding the towels for draping and throughout the case lint collected on the bovie tip, suture needles, and forcep tips.The patient was not adversely affected.No patient demographics were provided after multiple attempts to obtain.

• Brand Name: CV SET UP PACK (CVCHA)171
• Common Device Name: CARDIOVASCULAR PROCEDURE 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: 10891539
• Report Number: 1423537-2020-00566
• Device Sequence Number: 16501185
• Product Code: OEZ
• UDI-Device Identifier: 10887488305516
• UDI-Public: 10887488305516
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/23/2020

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: SCVBCCVCHB
• Device Catalogue Number: SCVBCCVCHB
• Device Lot Number: 499569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• 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