MAUDE Adverse Event Report: Medline Industries, LP Bulb Irrigation Syringe; SYRINGE,IRRIGATION,BULB,60ML,STERILE

Catalog Number	DYND20125
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury

• Brand Name: Bulb Irrigation Syringe
• Common Device Name: SYRINGE,IRRIGATION,BULB,60ML,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50951914
• Report Number: 1417592-2026-10526
• Device Sequence Number: 13136446
• Product Code: KYZ
• UDI-Device Identifier: 10080196031764
• UDI-Public: 10080196031764
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYND20125
• Device Lot Number: 96925090001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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