MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO FEP STRAIGHT CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	405011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the peripheral intravenous line was attempted in the left ac and, when the catheter was pulled out, the tip was found to be sheared off.Per reporter, an x-ray was done, and the portion of the device was seen on the x-ray.
Additional Manufacturer Narrative
No product nor photographs have been provided; therefore, no failure investigation could be performed on the product.The device history review shows no anomalies noted; all the samples passed testing, confirming compliance of the product with the specifications.A review of the complaints database has been performed, and no other complaint was found on the lot involved.Based on the evidence currently available, the investigation could not determine whether a quality related issue has resulted in the customer reported problem.

• Brand Name: JELCO FEP STRAIGHT CATHETER
• 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: 22872607
• Report Number: 3012307300-2025-09897
• Device Sequence Number: 5689472
• Product Code: FOZ
• UDI-Device Identifier: 15019315118333
• UDI-Public: (01)15019315118333(17)271031(10)6065037
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405011
• Device Lot Number: 6065037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown