MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; KIT,CATHETER,SUCTION,10FR,WHISTL,2 GLV

Catalog Number	DYND40970
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact on (b)(6) 2026, "the rn was utilizing the 10french suction catheter to suction the patient's mouth.While suctioning she noted that 2 pieces of the suction catheter had broken off in the patient's mouth.The patient was not biting on the catheter.There was not harm to the patient.The rn removed the pieces of the catheter from the patient's mouth.The patient had no difficulty breathing and did not choke on the suction catheter pieces.No follow up care or medical/surgical treatment was needed.The patient is doing well, no issues".No additional details are available related to the customer reported issue.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer contact on (b)(6) 2026, "the rn was utilizing the 10french suction catheter to suction the patient's mouth.While suctioning she noted that 2 pieces of the suction catheter had broken off in the patient's mouth".
Additional Manufacturer Narrative
Update to h6: type of investigation (b).Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).

• Brand Name: MEDLINE
• Common Device Name: KIT,CATHETER,SUCTION,10FR,WHISTL,2 GLV
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24830877
• Report Number: 1417592-2026-00399
• Device Sequence Number: 13058157
• Product Code: OFR
• UDI-Device Identifier: 10080196033294
• UDI-Public: 10080196033294
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND40970
• Device Lot Number: 48625060001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown