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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "i have been notified by our or manager that the tip suction yankauer no vent disp qtx71d887 (71-d887) is breaking during use.".
Additional Manufacturer Narrative
A user facility reported, "i have been notified by our or manager that the tip suction yankauer no vent disp qtx71d887 (71-d887) is breaking during use." deroyal industries, inc.Requested return of the device, but it has not yet been received.A supplier corrective action request (scar) will be issued to the supplier, (b)(4).This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information becomes available.
Additional Manufacturer Narrative
A user facility reported, "i have been notified by our or manager that the tip suction yankauer no vent disp qtx71d887 (71-d887) is breaking during use." deroyal industries, inc.Requested return of the device, and it was received on (b)(6) 2025.No lot number was provided with the complaint.Deroyal does not manufacture this product so no risk analysis is available for review.An inventory check was performed on 50 eaches pulled from the distribution facility and no errors were found.A complaint to sales ratio was conducted between (b)(6) 2024 through (b)(6) 2025 and found to be (b)(4).A supplier corrective action request (scar) was issued to the supplier, arrow medsource group limited.The supplier checked product inventory and no finished goods were found in the factory as well as no semi-finished products were found in production.Due to the unknown lot number, the supplier inspected three retention samples of various lot numbers.The dimensions of the yankauer head and joint connection for the 71-d87 were all within the range required by the technical drawings.Root cause: it is suspected that there is a mating issue between the handle of this yankauer and the joint of its connected end.Corrective and preventive action: maintain yankauer handle's molds before and after production to ensure their critical dimensions maintain dimensional accuracy post-use.During the production, assembly, and finished product inspection of 71-d887, the s-2 aql 1.0 standard was applied to the product's dimensions, with no dimensional nonconformities detected.To prevent this, potentially use the connector which has a maximum of 9.0mm internal diameter at the joint area as this would more effectively match with the 71-d887 yankauer.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• 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 changshou rd, 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 ; 8653622106
• MDR Report Key: 22749609
• Report Number: 1060680-2025-00046
• Device Sequence Number: 13151006
• Product Code: JOL
• UDI-Device Identifier: 00749756972444
• UDI-Public: 00749756972444
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/06/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown