MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO SAFETY PROTECTIV PLUS CATHETERS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	308000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date unknown.H3: device not received by manufacturer. 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 when the needle entered the vein, blood came out at hub prior to threading of catheter.The clinician reported hearing a "pop sound".There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The reported issue could not be confirmed.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): SMITHS MEDICAL ITALIA SRL; via della stazione, 2; latina scalo ; IT
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21139121
• Report Number: 3004187702-2025-00001
• Device Sequence Number: 7516831
• Product Code: FOZ
• UDI-Device Identifier: 10351688071330
• UDI-Public: (01)10351688071330(17)270509(10)6017262
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: 6017262
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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