MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PROTECTIV PLUS SAFETY IV CATHETER - RADIOPAQUE - 20GX 1IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 3067

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Iv catheter defective and caused nurse a near needlestick injury as the needle did not retract appropriately.Iv catheter examined with multiple staff members and compared with another iv catheter of the make/mode.The outer sheath of the iv catheter was missing.This was not identified when catheter removed from packaging until after the device was used on patient when nurse unable to retract device.Fda safety report id # (b)(4).

• Brand Name: PROTECTIV PLUS SAFETY IV CATHETER - RADIOPAQUE - 20GX 1IN
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; minneapolis MN 55442
• MDR Report Key: 13019752
• MDR Text Key: 282421400
• Report Number: MW5106109
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071217
• UDI-Public: 10351688071217
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3067
• Device Lot Number: 4186805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1