MAUDE Adverse Event Report: Arrow Medsource Group Limited Yankauer Suction Handle, Straight Tip; CATHETER AND TIP, SUCTION

Model Number	71-D887
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction

• Brand Name: Yankauer Suction Handle, Straight Tip
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): Arrow Medsource Group Limited; unit 1104, yueda 889 center; 1111 changshour road, jingan; shanghai, ; CH
• Manufacturer (Section G): DeRoyal Industries, Inc.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; +1(865)362-2106
• MDR Report Key: 50846091
• Report Number: 1060680-2026-00015
• Device Sequence Number: 18631346
• Product Code: JOL
• UDI-Device Identifier: 00749756972444
• UDI-Public: 00749756972444
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 71-D887
• Device Lot Number: CNWKD10-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown