MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC.; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Lot Number 201127

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2021

Event Type  malfunction  

Event Description

While administering turbulent flush, female connector, from footprint medical 1.9 fr single lumen silicone pic catheter, disconnected from line landing in patients bed.Picc line removed.

• Brand Name: NA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 12727 cimarron path; san antonio TX 78249
• MDR Report Key: 11841000
• MDR Text Key: 251144755
• Report Number: 11841000
• Device Sequence Number: 1
• Product Code: LJS
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 201127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1