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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/26/2020

Event Type  malfunction  

Event Description

Information was received indicating that the patient noted that the cadd disposable iv connector snapped while getting out of bed.Subsequently, patient was able to change the line.It was reported that the patient was concerned about getting an infection, since there was fluid on his clothing.The patient was advised to completely change cassette in use along with new line to prevent the issue.The patient was able to continue his life sustaining infusion with no interruption.No patient consequences were reported.No adverse effects were reported.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 11337890
• MDR Text Key: 232186337
• Report Number: 3012307300-2021-00091
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2021

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 Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR