MAUDE Adverse Event Report: Excelsior Medical, LLC Medline; SYRINGE, SWABFLUSH,10/10ML, W/SWABCAP

Catalog Number	EMZG711600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dry Mouth (4485); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: SYRINGE, SWABFLUSH,10/10ML, W/SWABCAP
• Manufacturer (Section D): Excelsior Medical, LLC; 1933 heck ave; neptune NJ 07753 -442
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50379296
• Report Number: 2027791-2026-00014
• Device Sequence Number: 5639729
• Product Code: QBP
• UDI-Device Identifier: 00363807000001
• UDI-Public: 00363807000001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: Lay User/Patient
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: EMZG711600
• Device Lot Number: 3145062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2025
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 149 LB