MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Headache (1880); Chemical Exposure (2570)

Event Date 08/20/2019

Event Type  Injury  

Event Description

Pt reported that the bag is ripping inside the cassette as he was mixing and was around 80ml volume, lot number not available.Pt stated he is experiencing a headache because contents did spill on his abdomen and feet.Cassette was discarded.Not available for return.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8936170
• MDR Text Key: 155934657
• Report Number: MW5089364
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 08/21/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Patient Sequence Number: 1
• Patient Age: 39 YR