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

Model Number 306001

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

Noting piv catheters that have a delayed fill of the catheter flash causing staff to use multiple attempts to place.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 16731739
• MDR Text Key: 313224159
• Report Number: 16731739
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30351688071181
• UDI-Public: (01)30351688071181
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/15/2023

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: 306001
• Device Lot Number: 4368107 & 4345761
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1