MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE

Catalog Number	DYND50130
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility (b)(6) 2024 "suction was used to suction any oral secretions with the tip of the suction, had been off and during the suction and caused a laceration of the right palate".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 "suction was used to suction any oral secretions with the tip of the suction, had been off and during the suction and caused a laceration of the right palate".Per the facility the laceration was described as "superficial but was still closed with chromic sutures".Per the facility the "patient is doing ok, no issues".No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: YANKAUER,BULB TIP,W/O VENT,RIGID,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL
• MDR Report Key: 19458911
• Report Number: 1417592-2024-00633
• Device Sequence Number: 20536155
• Product Code: JOL
• UDI-Device Identifier: 10080196034956
• UDI-Public: 10080196034956
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/04/2024

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?: No
• Device Catalogue Number: DYND50130
• Device Lot Number: 96923120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 56 KG