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

Model Number DYND20125

Patient Problem Insufficient Information (4580)

Event Date 02/28/2024

Event Type  malfunction  

Event 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
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18977354
• MDR Text Key: 338576594
• Report Number: 18977354
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10080196031764
• UDI-Public: (01)10080196031764((17)DYND20125(10)96923070002
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 03/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male