MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CO2 CANNULA,SSOFT,ADLT,7O2,7CO2,M,BLK

Catalog Number	HCS4568BS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tubing of the co2 cannula kinked during an unspecified eye procedure.Reportedly, the patient experienced de-saturation.Despite multiple good faith attempts, the reporting facility was unable or unwilling to provide additional information to the manufacturer.No adverse patient impact or medical intervention was originally reported.A sample was returned to the manufacturer.Sample evaluation is ongoing at this time.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the tubing of the co2 cannula kinked.
Additional Manufacturer Narrative
Investigation of the samples returned to the manufacturer has been completed.The returned samples were from lot number 40020070113.Upon visual inspection, the returned samples appeared to be in new condition.To date, no additional information related to the use of the product or the reported de-saturation incident has been received by the manufacturer.It is unknown if product from lot number 40020070113 was involved in the reported de-saturation incident.Model number hcs4568bs is made of material that is not kink-resistant as it is only intended to make soft round turns under the chin and behind the ears to under the nose.The reported product problem/issue was unable to be confirmed upon completion of the sample investigation.If additional relevant information becomes available another supplemental medwatch will be filed.

• Common Device Name: CO2 CANNULA,SSOFT,ADLT,7O2,7CO2,M,BLK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11591609
• Report Number: 1417592-2021-00058
• Device Sequence Number: 3279837
• Product Code: CCX
• UDI-Device Identifier: 10888277729070
• UDI-Public: 10888277729070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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 Catalogue Number: HCS4568BS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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