MAUDE Adverse Event Report: PICC LINE; STOPCOCK, I.V. SET

Model Number MS403

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2021

Event Type  malfunction  

Event Description

Extension tubing on picc line broke in two places, when going to flush line.Mckesson.Fda safety report id# (b)(4).

• Brand Name: PICC LINE
• Type of Device: STOPCOCK, I.V. SET
• MDR Report Key: 12780603
• MDR Text Key: 280711899
• Report Number: MW5105212
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MS403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female