MAUDE Adverse Event Report: AMSINO MEDICAL KUNSHAN CO. LTD. MEDICHOICE; MEDICHOICE SUCTION CATHETER 14FR STERILE

Model Number	0RSC14
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient number 1: per customer, the endotracheal tube suction catheter gets stuck in the endotracheal tube.The catheter is sticky.The complaint site indicates they were unable to ventilate patient during aortic dissection procedure resulting in patient oxygen desaturation.The patient had a cardiac arrest requiring cpr.
Additional Manufacturer Narrative
Based on the results of the investigation on the dhr records, no abnormalities were observed for the confirmed lot number 1901ak60a.The retained samples were reviewed and the inspection results confirmed that there were no abnormalities, the tubing surface was smooth and the tubing was soft and similar with other product lots.Samples were returned for the affected lot number 1901ak60a and inspection completed, no abnormities were found.A further in depth root cause analysis was completed and no risk point or abnormalities were found in the investigation of the manufacturing process.In addition, the reported incident has been entered in our tracking and trending program in order to continuously monitor for emerging trends in the marketplace.At this time no corrective action is required.

• Brand Name: MEDICHOICE
• Common Device Name: MEDICHOICE SUCTION CATHETER 14FR STERILE
• Manufacturer (Section D): AMSINO MEDICAL KUNSHAN CO. LTD.; 582 shipu lidu road; qiandeng town; kunshan city, jiangsu CN 21 5345; CH CN 215345
• Manufacturer (Section G): AMSINO MEDICAL (KUNSHAN) CO. LTD; 582 shipu lidu road; qiandeng town; kunshan city, jiangsu CN 21 5345; CH CN 215345
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005
• MDR Report Key: 14892638
• Report Number: 3003753847-2022-00001
• Device Sequence Number: 12332944
• Product Code: BSY
• UDI-Device Identifier: 10885632100246
• UDI-Public: 10885632100246
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022
• Report Date (Section F): 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0RSC14
• Device Catalogue Number: 13140RSC14
• Device Lot Number: 1901AK60A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female
• Date Report Sent to FDA: 07/05/2022