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

Model Number 306701

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  malfunction  

Event Description

Reported by pre op staff that lot #3719639 20 g iv catheter is having issues advancing catheter. The plastic piece you push forward to advanced is extremely difficulty to push forward. Pre op rn reported almost losing this line in pre op because of difficulty. Pre op rns reported this happening several times over the last week.

• 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: 8335181
• MDR Text Key: 136043288
• Report Number: 8335181
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/29/2019,02/01/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/13/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 306701
• Device Lot Number: 3719639
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage