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

Catalog Number	405311
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was leaking at the catheter site, which looked to have holes in it.There was unknown patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: 19 samples were received for evaluation.Samples were visually inspected and 6 of the 19 units showed an approximately 2.5 mm longitudinal physical damage on the catheter tube at about 1.4 mm distance from the nose.During the functional testing, the physical damaged observed on the 6 units resulted in leakage.It is possible that the defect originated during the assembly process in the manufacturing line.The type and position of the damage observed is compatible with the jaws of the catheter & needle tip inspection station.Review of the manufacturing records during production of this lot showed that no mechanical machine issues that would pertain to this issue were detected.Also, review of the dhr revealed that, during the manufacturing of the lot involved, no nonconformances have been raised that pertain the issue reported.No corrective action will be implemented at this moment; however, we will monitor the recurrence of this type of defect and if a trend will be identified, a corrective action will be recommended.

• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20611235
• Report Number: 3004187702-2024-00046
• Device Sequence Number: 20815613
• Product Code: FOZ
• UDI-Device Identifier: 15019315118340
• UDI-Public: (01)15019315118340(17)260718(10)4419290
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Expiration Date: 07/18/2026
• Device Catalogue Number: 405311
• Device Lot Number: 4419290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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