MAUDE Adverse Event Report: TRI-STATE DE MEXICO, S. DE R.L. DE C.V MEDLINE; AVA HF 9F 3L CVC STOCKBUNDLE -US

Catalog Number	STCVC11US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, we had an advanced venous access device that when the anesthesia provider put it in the patient it leaked and they removed it from the patient.There was no further information.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.
Event or Problem Description
According to the facility "we had an advanced venous access device that when the anesthesia provider put it in the patient it leaked and they removed it from the patient".

• Brand Name: MEDLINE
• Common Device Name: AVA HF 9F 3L CVC STOCKBUNDLE -US
• Manufacturer (Section D): TRI-STATE DE MEXICO, S. DE R.L. DE C.V; calzada presidente venustiano; carranza 301 desarollo industr; mexicali, baja california 21397 ,; MX 21397,
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24561271
• Report Number: 3004519921-2026-00008
• Device Sequence Number: 9422149
• Product Code: OES
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: STCVC11US
• Device Lot Number: 2025052390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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 Sex: Unknown