MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE,EAR/ULCER, RED, 2 OZ, STERILE

Catalog Number	URO70283
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on several occasions, most recently (b)(6) 2025, bulb syringes are "breaking with usage." the customer stated that a "new syringe obtained, or suction catheter used" after the incidents occurred.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that on several occasions, most recently (b)(6) 2025, bulb syringes are "breaking with usage.".

• Common Device Name: SYRINGE,EAR/ULCER, RED, 2 OZ, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23767217
• Report Number: 1417592-2025-00697
• Device Sequence Number: 18782199
• Product Code: KYZ
• UDI-Device Identifier: 10889942472208
• UDI-Public: 10889942472208
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/10/2025

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 Catalogue Number: URO70283
• Device Lot Number: 0332503A100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown