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

Lot Number 4199553

Device Problems Material Separation (1562); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

Iv was placed and when removing safety piece containing the needle to leave just catheter, only part of needle came back out and part stayed in the hub.Pt had to be stuck again and no needle stick occurred but staff could have been possibly stuck by exposed needle.Fda safety report id# (b)(4).

Event Description

Iv was placed and when removing safety piece containing the needle to leave just catheter, only part of needle came back out and part stayed in the hub.Pt had to be stuck again and no needle stick occurred but staff could have been possibly stuck by exposed needle.Fda safety report id# (b)(4).

• Brand Name: SMITHS MEDICAL PROTECTIV PLUS SAFETY IV CATHETER
• 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: 13472674
• MDR Text Key: 285356803
• Report Number: MW5107241
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4199553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1