MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE OPEN HEART DRP SH 36883 (ODSNB)654; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCVHDODSNC
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record review(dhr) did not indicate any exception that could lead to the reported incident.A review of the device history record for lot# 20200908-23-sh revealed the product was finished on the november 25, 2020.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.164g/10pcs.No sample was available at the time of this investigation; however, a photo was provided.A review of the photo showed lint found on the towel.According to supplier, operating room towel is made of cotton, so cotton fiber is born.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.(b)(4).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.The investigation revealed no abnormal situation occurred during production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.No action taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Upon opening the open heart pack (scvhdodsnc) for open heart procedure, the clinician noticed linting from the blue towels in the pack and on the towel (pwtb04-stm).The towels were not used on a patient.No injury or adverse effect reported.

• Brand Name: OPEN HEART DRP SH 36883 (ODSNB)654
• 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: 11979906
• Report Number: 1423537-2021-00641
• Device Sequence Number: 11898347
• Product Code: OEZ
• UDI-Device Identifier: 10887488787343
• UDI-Public: 10887488787343
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: SCVHDODSNC
• Device Catalogue Number: SCVHDODSNC
• Device Lot Number: 575652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/10/2021
• Patient Sequence Number: 1