MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECTIV PLUS SAFETY I. V. CATHETERS RADIOPAQUE JELCO 20G; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 3066

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

Rn placing iv catheter for infusion therapy and this rn noticed angiocatheter was giving resistance.Rn threading catheter into vein after noticing blood return.A small amount of extra force was needed to successfully thread catheter into vein properly, angiocatheter having slight trouble while also attempting to retract needle into safety area.Fda safety report id # (b)(4).

• Brand Name: PROTECTIV PLUS SAFETY I. V. CATHETERS RADIOPAQUE JELCO 20G
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12835691
• MDR Text Key: 281034300
• Report Number: MW5105437
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3066
• Device Lot Number: 4144805
• 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
• Patient Age: 37 YR
• Patient Sex: Prefer Not To Disclose