MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL JELCO 20G X 1" PROTECTIV PLUS SAFETY I; CATHETER, INTRAVASCULAR THERAPEUTIC SHORT TERM

Lot Number 3828846

Device Problems Product Quality Problem (1506); Failure to Disconnect (2541); Output Problem (3005)

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

Event Date 08/13/2019

Event Type  malfunction  

Event Description

Smiths medical 20g x 1" iv catheter malfunction.The needle would not disconnect from the hub during iv insertion.Lot number: 3828846.Fda safety report id# (b)(4).

• Brand Name: SMITHS MEDICAL JELCO 20G X 1" PROTECTIV PLUS SAFETY I
• Type of Device: CATHETER, INTRAVASCULAR THERAPEUTIC SHORT TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8922727
• MDR Text Key: 241261448
• Report Number: MW5089244
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2022
• Device Lot Number: 3828846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 0