MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO CONVENTIONAL JELCO IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 4033-AI

Device Problem Difficult to Insert (1316)

Patient Problem Phlebitis (2004)

Event Type  malfunction  

Event Description

It was reported that there were six (6) patients in the emergency room with dysfunctional venous accesses due to extravasation.Multiple punctures, change of accesses and increase of phlebitis cases as result.No medical intervention needed.Additional information was requested; however, no further information was received.

Manufacturer Narrative

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.

Manufacturer Narrative

H6: health impact and evaluation codes: updated h10: a device history record (dhr) review didn't show any anomaly related to the referenced defect.No product sample nor photos were 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.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4) corrected data: g1, h3.

• Brand Name: JELCO CONVENTIONAL JELCO IV CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer (Section G): NULL; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15336672
• MDR Text Key: 305520374
• Report Number: 3012307300-2022-17292
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4033-AI
• Device Lot Number: 4249664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1