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

Catalog Number	308500
Medical Device Problem Codes	Material Twisted/Bent (2981); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that with the device when trying to start an iv on a patient that the device was bent and did not deploy.There was patient involvement, and no patient harm was reported.
Additional Manufacturer Narrative
Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.The dhr review shows no anomaly was recorded during the manufacturing of the lot involved.Additionally, no maintenance tickets that would pertain to this issue were found during production of this lot.Review of the complaints database showed no other complaint on the lot involved.Review of the database was extended to all the lots belonging to the code 308500, showing no other complaint logged in the last three years (from (b)(6) 2021 to (b)(6) 2024) alleging a similar issue.On the basis of the available evidence and with no product available for evaluation, we cannot confirm whether a quality related issue has resulted in the customer reported problem.

• Brand Name: JELCO PROTECT PLUS-W SAFETY IV CATHETER-RADIOPAQUE
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19714993
• Report Number: 3004187702-2024-00022
• Device Sequence Number: 15588829
• Product Code: FOZ
• UDI-Device Identifier: 10351688071309
• UDI-Public: (01)10351688071309(17)250301(10)4238984
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/13/2024

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: 03/01/2025
• Device Catalogue Number: 308500
• Device Lot Number: 4238984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2022
• 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