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

Catalog Number 4030-AI

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received indicating that while in use of a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter, it was noted that some blood had come back, the vein had broken down when the user wanted to move the catheter back into the vein.It was also reported that by removing the catheter, the user realized that the catheter needle had pierced the white plastic catheter.No further adverse effects were reported.

• Brand Name: JELCO
• 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
• MDR Report Key: 12470774
• MDR Text Key: 271369862
• Report Number: 3012307300-2021-09360
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4030-AI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1