MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE CONVENIENCE KIT; TRAY,18G CPNB, 20G STYLETED

Catalog Number	DYNJRA9040
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact on (b)(6) 2026, "the catheter went in without incident, but when the pacu nurse attached the pain pump it was alarming occlusion" and "i attempted to reattach and troubleshoot the line with no avail." the customer contact noted "plastic poking out of the end of the catheter and called an anesthesiologist to look at it" and "the plastic was pulled and continued to come out, almost like another line within the catheter." the customer contact stated, "we removed the catheter and placed another one" and "the patient required follow-up on pod 1." the customer contact indicated the patient is "stable, no issues at this time." no serious injuries were reported related to the incident.No additional details are available related to the customer reported issue.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 customer contact on (b)(6) 2026, "the catheter went in without incident, but when the pacu nurse attached the pain pump it was alarming occlusion" and "plastic poking out of the end of catheter".The customer contact stated, "we removed the catheter and placed another one.".
Additional Manufacturer Narrative
Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).

• Brand Name: MEDLINE CONVENIENCE KIT
• Common Device Name: TRAY,18G CPNB, 20G STYLETED
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24638479
• Report Number: 1417592-2026-00230
• Device Sequence Number: 18591214
• Product Code: OFT
• UDI-Device Identifier: 10193489830514
• UDI-Public: 10193489830514
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 05/31/2026
• Device Catalogue Number: DYNJRA9040
• Device Lot Number: 24EBR228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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
• Patient Age: 85 YR
• Patient Sex: Male