MAUDE Adverse Event Report: ICU MEDICAL (SM PRODOTTI) ITALIA S.R.L PROTECTIV PLUS-W 22G 1 25 BLUE MLAT OUS 200/CA; CATHETER,INTRAVASCULAR,THERAPEUTIC

Catalog Number	308000
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.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 found black impurities on the puncture catheter.The customer also verbally complained that the connection between the 308000 indwelling needle catheter and the catheter is relatively loose and prone to falling off.There was no patient involvement.
Event or Problem Description
It was further reported that the catheter had burrs.
Additional Manufacturer Narrative
H3: updated b5 to document catheter burrs.
Additional Manufacturer Narrative
D3: updated.D9 - date returned to mfr: 30_apr-2026.H3 and h6 codes: updated.One sample was returned for evaluation.A review of the lot history revealed no nonconformities that could have contributed to the reported complaint.Visual inspection did not confirm the presence of burrs or any surface irregularities on the puncture catheter.The reported issue could not be linked to a specific cause, and the root cause could not be identified.It is not anticipated that the reported malfunction would result in interruption of therapy or serious injury.
Event or Problem Description
It was further reported that the catheter had burrs.

• Brand Name: PROTECTIV PLUS-W 22G 1 25 BLUE MLAT OUS 200/CA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC
• 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: 24641070
• Report Number: 3012307300-2026-02610
• Device Sequence Number: 15902019
• Product Code: FOZ
• UDI-Device Identifier: 10351688071330
• UDI-Public: (01)10351688071330(17)280613(10)6126333
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: 308000
• Device Lot Number: 6126333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 06/11/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/13/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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