MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TUBES; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

Patient reported with last 2 monthly supply shipments all of the cassettes lot 4396110 have 2 metal staples holding the cassette tubing down on top of cassette placed 1/2 in apart instead of the single plastic bar between the 2 green plastic pieces that are under the blue clip when removed.Pt reported hi pressure alarms with about 10 out of 30 cassettes that resolved when pt removed the 2 staples.Also, the 60 inch ext tubing is not packaged as securely coiled to prevent kinks and there are multiple kinks in the tubing lot 4387695 causing increased hi pressure alarms that pt is able to resolve by manually smoothing the tubing kinks.This has occurred in about 8 out 30 tubing¿s.Smith cadd 100 ml flow stop cassettes and smiths 60 in ext tubing.Reference reports: #mw5149511, #mw5149512, #mw5149513, #mw5149514, #mw5149515, #mw5149516, #mw5149517, #mw5149518, #mw5149519, #mw5149520, #mw5149521, #mw5149522, #mw5149523, #mw5149524, #mw5149525, #mw5149527, #mw5149528.

• Brand Name: TUBES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18393291
• MDR Text Key: 331483541
• Report Number: MW5149526
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic