MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 24'' 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21723024

Device Problems Crack (1135); Obstruction of Flow (2423); Defective Device (2588)

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

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Patient stated that on (b)(6) 2023 she went to change her cassette and had an occlusion alarm on her remunity pump.She looked down at her site and noticed that the plastic part of the cleo infusion set that sits on top of the skin had "crumbled" and was "cracked-in-two".Patient placed a new site on (b)(6) 2023 and did not have any interruption in therapy (meaning no missed doses and reported no adverse events).Patient states she did not have any pain with the incident and has no clue how it happened.Patient does not have defective product available for return-it was discarded.Lot number/expiration is not available.Both remunity pumps are in working order without issue.No issues with new site.Unknown if md aware.No additional information known.Reported to(b)(6) by: patient/caregiver.

• Brand Name: INF SET CLEO 24'' 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16984010
• MDR Text Key: 315859933
• Report Number: MW5117760
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21723024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2023
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female