MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. STERILE BULB IRRIGATION SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number	DYND20125
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease.Procedure: pacemaker removal.Upon opening the sterile packet with the bulb inside, there was an unknown substance inside the syringe.The image looks as though it could be dried tape.Syringe was not used, no known harm to patient.

• Brand Name: STERILE BULB IRRIGATION SYRINGE
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18977354
• Report Number: 18977354
• Device Sequence Number: 20386718
• Product Code: KYZ
• UDI-Device Identifier: 10080196031764
• UDI-Public: (01)10080196031764((17)DYND20125(10)96923070002
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/05/2024
• Report Date (Section F): 03/05/2024

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: DYND20125
• Device Catalogue Number: DYND20125
• Device Lot Number: 96923070002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• 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 Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 03/05/2024