MAUDE Adverse Event Report: IV EXTN SET 12" MICROBORE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Per many from md office, patient was in the er who is on iv veletri via picc line.She has visited the er twice in the last 3 days for cracked clave connectors.She received these in her last shipment and suspects they are faulty.She is also asking for additional extensions as she has a picc line and can¿s reach the connection without it, lot number is unknown.Unknown no missed dose.Unknown if patient has the defective product hand for possible return to the manufacturer.No further information provided all known information is contained in this report.Veletri directions: reconstitute contents of vial with 5 ml diluent and mix cassette as directed.Infuse continuously per md orders.Dose range: 1-150 ng per kg per min.Reported to (b)(6) by: health professional.

• Brand Name: IV EXTN SET 12" MICROBORE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 14624096
• MDR Text Key: 293648563
• Report Number: MW5110159
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2022
• Patient Sequence Number: 1
• Patient Sex: Female