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

Model Number 21710624

Device Problem Failure to Prime (1492)

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

Event Type  malfunction  

Event Description

Iv remodulin - self mix" spontaneous call received from patient to report patient is having difficulty priming her extension set.After multiple steps to troubleshoot, patient was able to return infusion with new extension set.Faulty extension set lot# 4303046.No other details known.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did we [mfr] replace the device? no; pt had back-up.Did the pt have a backup device they were able to switch to? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16067576
• MDR Text Key: 306409571
• Report Number: MW5114042
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 12/21/2022

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: 21710624
• Device Lot Number: 4303046
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female