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

Model Number MMT-392

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

Spontaneous, pt stating her needle seemed bent and she was worried it was not infusing her medication.Remote stated that it was infusing with 13 hrs remaining.She did not notice any dripping of medication, but she did state that there was tape bundled around the catheter to keep it in place.Advised pt to clamp current tubing, cap it, and change her site.Pt found the necessary supplies.Pt stated she moved around a bit and watched it pop out within the last hour or so.She endorsed no shortness of breath or side effects.Advised she can continue on her regular rate.After the tubing was removed and clamped, she stated that "she got it from here" regarding the rest of the change.Unknown if pt still has defected device on hand.Needles used to infuse c-treprostinil at above dose and frequency.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET QUICK SET 23" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 16379146
• MDR Text Key: 309664563
• Report Number: MW5114931
• 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: 01/24/2023

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: MMT-392
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Patient Sequence Number: 1
• Treatment: C-TREPROSTINIL.
• Patient Age: 60 YR
• Patient Sex: Female