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

Catalog Number 4033-AI

Device Problems Break (1069); Human-Device Interface Problem (2949); Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/28/2022

Event Type  Injury  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

Event Description

It was reported that a newborn patient was cannulated for a peripheral iv at 09h30.At 19h20 the iv site was leaking.On removal of the jelco it was noted only 5mm of the catheter was presentable.Patient required cardiologist assessment and follow up.X-ray and echogram ordered with cardiologist.Remainder of jelco needle was located in the right ventricle of the heart on cardiac echo.Patient was discharged from hospital with no further treatment.Additional information received on (b)(6) 2022 when we requested the current status of the patient.We were informed the only info available was that the patient has been discharged from the hospital and apart from the x-ray and echogram, but no surgical intervention to remove and no other treatment has been rendered at this time.

• Brand Name: JELCO RADIOPAQUE CATHETER
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; menlyn central office bldg.; minneapolis, MN 55442
• MDR Report Key: 14853970
• MDR Text Key: 294931804
• Report Number: 3012307300-2022-12661
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4033-AI
• Device Lot Number: 4235742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Sex: Female
• Patient Weight: 3 KG