MAUDE Adverse Event Report: SMITHS MEDICAL 20 GAUGE ANGIOCATH JELCO

Lot Number 3386421

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/26/2017

Event Type  malfunction  

Event Description

With iv insertion the back pressure popped the safety hub off as soon as catheter inserted and threaded into vein.This malfunctioning of this jelco has occurred on 5 occasions in the last 3 weeks.Upon inserting an iv line where the safety hub of the needle popped off during advancement of the angiocath causing blood to spurt out.Needle used was a 20g.Dates of use: (b)(6) 2017 - (b)(6) 2017.Diagnosis or reason for use: pre-surgical placem,ent for hydration and medications.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: 20 GAUGE ANGIOCATH JELCO
• Type of Device: 20 GAUGE ANGIOCATH JELCO
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6556988
• MDR Text Key: 74933973
• Report Number: MW5069670
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3386421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1