MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; YANKAUER,BULB TIP,ON/OFF CONTROL,STERILE

Catalog Number	OR164
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that yankauer broken in surgery after being used for suction, when surgeon was removing it from the "patient's" belly.
Additional Manufacturer Narrative
According to the facility, during surgery the device was noted to be broken while out of the patient; the product was inserted into the site of use (incision) and removed, and it was discovered to be broken while out of the patient, prior to re-insertion into the incision site.A sample was received for evaluation and visual inspection was conducted with the provided sample; finished good production records were reviewed and component trending was reviewed.Based on the visual inspection of provided sample, the complaint was confirmed.The cause code was documented as ¿comp./part defective, broke¿; the vendor has been notified and the supplier quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: YANKAUER,BULB TIP,ON/OFF CONTROL,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50671184
• Report Number: 1417592-2026-33853
• Device Sequence Number: 18448661
• Product Code: JOL
• UDI-Device Identifier: 40888277107466
• UDI-Public: 40888277107466
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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
• Device Catalogue Number: OR164
• Device Lot Number: 18324020002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/08/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown