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	308700
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- customer email reported as (b)(6) if addition information become available report will be updated.H3/h6: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated in the report that the doctor performed an indwelling needle puncture for a patient undergoing a painless outpatient gastrointestinal endoscopy.After seeing blood return during the puncture, when the catheter assembly was advanced into the blood vessel, the needle safety device detached.After detachment, blood flowed out from the catheter assembly, causing the patient to feel dissatisfied, leading to blood pressure fluctuations and affecting anesthesia and the gastrointestinal endoscopy.There was patient involvement/ no harm reported.
Additional Manufacturer Narrative
H3: one used sample was received for evaluation.Visual inspection of the sample found no leaks.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.A blunt canula and a syringe was used to draw blood from the sampling port; the syringe was able to draw blood without air bubbles.The customer issue was not confirmed through the analysis of the returned sample since there was no leaking found; therefore, the unit was found within specification.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot.

• 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 04100 ; IT 04100
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23924850
• Report Number: 3012307300-2025-13909
• Device Sequence Number: 13015043
• Product Code: FOZ
• UDI-Device Identifier: 10351688071323
• UDI-Public: (01)10351688071323(17)270528(10)6008765
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 308700
• Device Lot Number: 6008765
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Male