MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CONVENTIONAL SERIVA CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC,

Catalog Number 8353

Device Problems Difficult to Insert (1316); Dull, Blunt (2407)

Patient Problem Phlebitis (2004)

Event Date 11/13/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510k is unknown, no product information has been provided to date.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 Description

It was reported that the quality defect presented by the product was blunt tip.When the catheter was inserted with the needle, the catheter opened and went back and retracted.The patients presented phlebitis and the catheter had to be changed.

Manufacturer Narrative

Other, other text: h6 - health impact, results and conclusion codes: updated device evaluation: 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 device history report (dhr) is stored at the supplier.Supplier has been notified of item fault.

• Brand Name: JELCO CONVENTIONAL SERIVA CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC,
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; de parque lefevre; minneapolis, MN 55442
• MDR Report Key: 16034999
• MDR Text Key: 307592551
• Report Number: 3012307300-2022-28121
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: PM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 8353
• Device Lot Number: 3126519D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1