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 Codes	Fluid/Blood Leak (1250); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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It was reported that the product detached from the sharp hub when the catheter was advanced and the sharp was retracted.When this happened, the catheter free flowed with blood return and created a safety risk with lots of blood on the patient/stretcher, etc.The facility had multiple staff members who encountered the same situation.Sample is not available for return.There were patient involvement and no harm reported.
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• 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 '0401 ; IT '0401
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 60045 ; 2247062300
• MDR Report Key: 23574138
• Report Number: 3012307300-2025-12516
• Device Sequence Number: 15952596
• Product Code: FOZ
• UDI-Device Identifier: 10351688071330
• UDI-Public: (01)10351688071330(17)271031(10)6065032
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 308000
• Device Lot Number: 6065032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/17/2025
• 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