MAUDE Adverse Event Report: INF SET QUICK SET 23" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Priming Problem (4040)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Pt was performing routine sq remodulin cartridge change but stated tubing is not priming correctly.The made sure there were no kinks/clamps in the tubing but no drops coming from the end.I had pt replace tubing with new set and they were able to prime successfully, seeing drops come out the other end.Pt was able to connect and resume infusion.Unknown lot number and expiration date.Did the reported product fault occur while in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? no.Did we replace device? no.Did the patient have a backup device they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Does the pt have the defective product on hand for possible return to the manufacturer? unknown.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET QUICK SET 23" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 15055374
• MDR Text Key: 296261703
• Report Number: MW5110952
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female