MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO - 24G PROTECTIV PLUS SAFETY IV CATHETER-RADIOPAQUE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 4422644

Patient Problems Abrasion (1689); Needle Stick/Puncture (2462)

Event Date 02/21/2024

Event Type  Other  

Event Description

The safety function of piv (peripheral intravascular) catheter needle cover failed.This malfunction caused a needle stick injury to the healthcare personnel and skin abrasion/scrape to a newborn patient.The nurse correctly activated the needle cover, but the needle stayed exposed.

• Brand Name: JELCO - 24G PROTECTIV PLUS SAFETY IV CATHETER-RADIOPAQUE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18779186
• MDR Text Key: 336231699
• Report Number: MW5151933
• 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: 02/22/2024

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?: No
• Device Operator: Health Professional
• Device Lot Number: 4422644
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1