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

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Per spontaneous call from patient "patient stated that she has an allergy (symptom details unknown) to the dressing change tray central line and requested to remove that rx so that we dont send it out next time.Said that she is also having issues with the cassettes since the last couple of times (dates not reported) that they are leaking but pt has extras of those so pt said if it continues happening then she will call back to discuss with rph and said that she didn't want to speak to rph at the moment about it".Unknown if faulty supplies are available for investigation, lots and expiration dates were not reported.No additional information or dates reported.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11848120
• MDR Text Key: 251895416
• Report Number: MW5101422
• Device Sequence Number: 2
• 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: 05/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1