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

Catalog Number	328000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer. a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the product had a filter bleed, which is intended to be a line where blood does not come in contact with nurse.There was no reported patient involvement.
Additional Manufacturer Narrative
H2) device evaluation: d3 manufacturer establishment name updated.D9 date returned to manufacturer: 7/9/2025.H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, and the customer problem was not able to be duplicated.One needle guard assembly without catheter assembly and sheath was returned and there was evidence of blood pooling into the guard and nose components indicative of an issue during use, however there was no cannula gaping or damage to porous barrier noted that could potentially result in the reported leakage.Of note, the image taken upon receipt at the decontamination site displayed drops in the end cap component consistent with blood pooling in the guard migrating outside the flash chamber where the porous barrier was located.Dried blood residue was identified in the flashback chamber and showed normal evidence of flash with no leakage between porous barrier and flash chamber.It should be noted that during use, the valve was not intended to prevent backflow of blood in the guard.Without the catheter assembly for the returned sample to evaluate for potential valve functionality issues, the complaint cannot be confirmed as the result of a manufacturing nonconformance, and root cause is unknown.

• Brand Name: JELCO PROTECTIV CATHETER
• 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: 22160189
• Report Number: 3012307300-2025-06718
• Device Sequence Number: 8907084
• Product Code: FOZ
• UDI-Device Identifier: 10351688081964
• UDI-Public: (01)10351688081964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Catalogue Number: 328000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown