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

Catalog Number 4036-AI

Device Problem Difficult to Insert (1316)

Patient Problems Extravasation (1842); Phlebitis (2004); Needle Stick/Puncture (2462)

Event Date 07/27/2022

Event Type  Injury  

Event Description

It was reported that six patients had dysfunctional venous accesses due to extravasation.Multiple punctures, changes of venous accesses, and cases of phlebitis increased.A specialist performed a technical demonstration with the device to the personnel and did a revision round with the patient safety manager.No further information is known.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample photo was received for evaluation.Visual inspection found potential product defects are not visible.No functional testing could be performed as no samples were received.The reported issue could not be confirmed per picture provided for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: JELCO IV CONVENTIONAL CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15563817
• MDR Text Key: 301364625
• Report Number: 3012307300-2022-22590
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K990236
• 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
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4036-AI
• Device Lot Number: 4222564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other