MAUDE Adverse Event Report: CONMED CORPORATION CONMED FLEXITIP; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	000216
Health Effect - Clinical Codes	Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Adult female with history of liver cirrhosis d/t alcohol abuse.Admitted to icu due to recent abdominal pain with n/v and bloody stools.Procedure: egd with chip placement.Sclerotherapy needle primed and functioned normally when tested.When it was being used during the procedure, the needle would not advance.Another needle obtain and used to complete the procedure.After the procedure, when the 1st needle was inspected, the needle still would not advance.No known harm to patient, minor delay in procedure.Manufacturer response for needle, aspiration and injection, disposable, conmed flexitip (per site reporter) will obtain.

• Brand Name: CONMED FLEXITIP
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 13534206
• Report Number: 13534206
• Device Sequence Number: 5115179
• Product Code: GAA
• UDI-Device Identifier: 30653405051163
• UDI-Public: (01)30653405051163(17)251029(10)202010304
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/02/2022
• Report Date (Section F): 02/02/2022

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: 000216
• Device Catalogue Number: 000216
• Device Lot Number: 202010304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 98 KG
• Date Report Sent to FDA: 02/02/2022