MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT,OPEN HEART CON (HCOB )933; CARDIOVASCULAR PROCEDURE KIT

Model Number	PVCGOHCOB
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exceptions that could lead to the reported incident.The average linting data is 0.157g/10pcs.No sample was available at the time of investigation.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suction 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.(=(b)(4)/(b)(4)pieces).In the folding process, supplier used one cloth pad under (b)(4)pieces semi-finished products to avoid linting stuck onto the products during product's transfer.The root cause could not be determined.The complaint information was shared with 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 on the blue towels pwtb04-stm from open heart kit, pvcgohcob.Lint was found prior to procedure with no delay or affect to patient.No clinical data or patient demographics were provided after numerous attempts to obtain.

• Brand Name: KIT,OPEN HEART CON (HCOB )933
• 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: 11812099
• Report Number: 1423537-2021-00635
• Device Sequence Number: 14389672
• Product Code: OEZ
• UDI-Device Identifier: 10888439839852
• UDI-Public: 10888439839852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: PVCGOHCOB
• Device Catalogue Number: PVCGOHCOB
• Device Lot Number: 554772
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/12/2021
• 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