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

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient reported that she had to waste a cassette because she noticed that there was a hole in the cassette ("where the plastic comes out a little bit, there was a leak").Lot number and expiration date is unknown.No other information or dates are known.Did the patient have a backup cassette they were able to switch to? yes, if yes, was the patient able to successfully continue their infusion? yes.Is the infusion life- sustaining? yes.What is the outcome of the event? resolved? ongoing? resolved.Did the product fault occur while in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available to be returned for investigator? yes, did we [mfr] replace cassette? yes.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.; minneapolis MN
• MDR Report Key: 12518568
• MDR Text Key: 273313043
• Report Number: MW5104157
• 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
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1