MAUDE Adverse Event Report: ICU MEDICAL, INC. JELCO PRO CATHETER 22 X 1; CATHETER,INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	305006
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	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient was administered with iv catheter, but upon removal, it was discovered that the end plastic catheter piece had detached from the hub and remained lodged in the patient¿s arm.Vascular surgical intervention was required to remove it.There was patient involvement and patient was unable to work for the remainder of the week without compensation due to the required surgery.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One photo was returned for one (1) used device was received for evaluation.Based on resolution of photo, root cause could not be defined with confidence.No product was returned, the investigation could not confirm.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Additional Manufacturer Narrative
One used catheter assembly, with third-party extension set and without severed tube, needle guard assembly, sheath and packaging, and a photo of the device were returned for analysis.Sample and photo were visually evaluated for potential nonconformances.The sample and photo displayed evidence of catheter tube severance, specifically within the catheter hub nose.Review of manufacturing logbook notes identified no definitive root cause for the observed catheter severance.The probable cause, however, is due to a variation in technique.Per ifu extreme care must be taken not to cut the catheter, as the use of sharp implements near the device may result in a tube severance during use.

• Brand Name: JELCO PRO CATHETER 22 X 1
• Common Device Name: CATHETER,INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22302053
• Report Number: 3012307300-2025-07454
• Device Sequence Number: 15594053
• Product Code: FOZ
• UDI-Device Identifier: 10351688071118
• UDI-Public: (01)10351688071118(17)270619(10)6021639
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305006
• Device Lot Number: 6021639
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 12/15/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/11/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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 Sex: Unknown