MAUDE Adverse Event Report: CYTOPHIL, INC RENU TRANSORAL NEEDLE - DOUBLE BEVEL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	210423
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor was performing a vocal fold injection when the tip of the needle broke off and the patient swallowed.Later that day, a ct of the abdomen/pelvis revealed 2.8 cm linear radiopaque foreign body located within the lumen of the mid ileum without evidence of perforation or penetration of the bowel.Supine abdominal x-ray two days later revealed the linear metallic foreign body overlying the right parasagittal pelvis, and as seen on the current limited field-of-view abdominal x-ray, the same metallic foreign body is no longer visualized, presumably having been in the rectum and evacuated spontaneously.No evidence to suggest bowel perforation, i.E.Either free air or extraperitoneal gas collection.Patient safely discharged a few days later in good condition.

• Brand Name: RENU TRANSORAL NEEDLE - DOUBLE BEVEL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): CYTOPHIL, INC; 2485 corporate circle, unit 2; east troy WI 53120
• MDR Report Key: 9155816
• Report Number: 9155816
• Device Sequence Number: 16786145
• Product Code: GAA
• UDI-Device Identifier: 00856509002669
• UDI-Public: (01)00856509002669(10)Q912-00031(17)210423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/02/2019
• Report Date (Section F): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 210423
• Device Catalogue Number: 12-000-00-ND1
• Device Lot Number: Q912-00031
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1
• Patient Weight: 91
• Date Report Sent to FDA: 10/03/2019