MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. CADD MEDICATION CASSETTE RESERVOIR; SET, I.V. FLUID TRANSFER

Lot Number 3607927

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Inbound, pt reports that when she mixed one of her cassettes, she noticed that the cassette was leaking and there was a tear in the bladder of the cassette lot 3607927.Not available for return.No further details provided.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.
• MDR Report Key: 8014449
• MDR Text Key: 125521862
• Report Number: MW5080885
• Device Sequence Number: 0
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3607927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1