MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 306501

Device Problems Bent (1059); Kinked (1339)

Patient Problem Infiltration into Tissue (1931)

Event Date 06/12/2017

Event Type  malfunction  

Event Description

Continue to have issues with iv catheters that are too bendable and kink and cause infiltration.Reported this in previous submission.This event makes a total of 8 reported events since mid may.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 6680662
• MDR Text Key: 78816053
• Report Number: 6680662
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/14/2019
• Device Model Number: 306501
• Device Lot Number: 3319315
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other