MAUDE Adverse Event Report: ICU MEDICAL (SM PRODOTTI) ITALIA S.R.L JELCO SAFETY PROTECTIV PLUS CATHETERS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	306001
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Vasculitis (2004); Swelling/ Edema (4577)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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.
Event or Problem Description
It was reported that a phlebitis occurred in several patients following the insertion of catheters in the hospital, with the onset of symptoms for some patients appearing within 24 hours after catheter placement.The packaging is intact and no visible defect was observed.However, during catheter insertion, there was no blood return even though the device was correctly positioned in the vein.Several clinical signs were reported, including edema, pain, significant redness, and in one case a thrombosis.The affected insertion sites were located on the upper limbs (left and right).The nurses performing the insertions had differing levels of expertise, ranging from beginner to expert within the care unit.The patient initials are (b)(6), female, born on (b)(6) 1996.There was patient involvement.
Additional Manufacturer Narrative
A device history record (dhr) 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.

• Brand Name: JELCO SAFETY PROTECTIV PLUS CATHETERS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL (SM PRODOTTI) ITALIA S.R.L; via della stazione, 2; latina scalo ; IT
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24500835
• Report Number: 3012307300-2026-01970
• Device Sequence Number: 10510104
• Product Code: FOZ
• UDI-Device Identifier: 10351688071187
• UDI-Public: (01)10351688071187
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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 Catalogue Number: 306001
• Device Lot Number: 6150679
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/24/2026
• 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 Age: 29 YR
• Patient Sex: Unknown