MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,IV,SURESITE SLIDE,22G X 1"

Catalog Number	DYNSCS22100Z
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025 leaking was observed from the left antecubital fossa iv site prior to transfer to pacu and it was discovered that the "tip of the catheter had disconnected from the hub of the iv.".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 leaking was observed from the left antecubital fossa iv site prior to transfer to pacu and it was discovered that the "tip of the catheter had disconnected from the hub of the iv." the customer said that an intraoperative ultrasound and venotomy of the left ac did not locate the tip of the device.The customer reported that immediately after surgery, the patient was "sent for another ultrasound on the left upper extremity with a cardiologist" with negative results.The customer stated that the patient is scheduled for "an echo" and that the patient is "stable and doing well." no additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: CATHETER,IV,SURESITE SLIDE,22G X 1"
• 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: 23073958
• Report Number: 1417592-2025-00481
• Device Sequence Number: 15951777
• Product Code: FOZ
• UDI-Device Identifier: 10888277667549
• UDI-Public: 10888277667549
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/17/2025

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: DYNSCS22100Z
• Device Lot Number: 27824100002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 54 KG