MAUDE Adverse Event Report: ICU MEDICAL ITALIA SRL JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	405011
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that they placed 22 gauge iv in the left foot.The line would not flush so they decided to remove the catheter while continuing to look for iv access on the other limbs.As they removed the catheter, they heard a pop and inspected the remaining piece of the catheter as it looked short.They looked at the site and did not see any of the remaining piece of the catheter at the insertion site, on the bed or on the nearby 4x4s.While waiting for general surgery, they did the ent portion of the case and also looked at the insertion site with the ultrasound.All parts of the foreign body of the catheter were removed and intact.There was a delay of therapy.Prolonged anesthesia due to surgical removal of retained piece of catheter.There was a patient involvement and there was a patient injury.
Additional Manufacturer Narrative
A device history record review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
D3 - postal code: corrected.

• Brand Name: JELCO
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL ITALIA SRL; via della stazione, 2; latina scalo 0401 ; IT 0401
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25135398
• Report Number: 3012307300-2026-04777
• Device Sequence Number: 13125196
• Product Code: FOZ
• UDI-Device Identifier: 15019315118333
• UDI-Public: (01)15019315118333(17)280912(10)6145510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405011
• Device Lot Number: 6145510
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Unknown