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

Model Number	306001
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Needle Stick/Puncture (2462)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that while initiating an intravenous (iv) line, the needle was withdrawn from the cannula and placed on the bed.As it was being picked up for disposal, it pricked the left pinky finger, causing bleeding.The cannula appeared to be defective, as its safety locking mechanism did not work.

• Brand Name: JELCO SAFETY PROTECTIV PLUS CATHETERS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL, INC., SOUTHINGTON CT; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22319786
• Report Number: 3012307300-2025-07556
• Device Sequence Number: 8924418
• Product Code: FOZ
• UDI-Device Identifier: 10351688071187
• UDI-Public: (01)10351688071187
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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 Model Number: 306001
• Device Catalogue Number: 306001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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