MAUDE Adverse Event Report: UNOMEDICAL A/S INF SET QUICK SET23" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-392

Device Problems Crack (1135); Leak/Splash (1354); Incomplete or Missing Packaging (2312); Defective Device (2588)

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

Event Type  malfunction  

Event Description

Spontaneous;.Pt's mother complaining rj defective needle sets.A few days ago one of the needle sets was missing a needle, so it was discarded, today there was a small crack and subsequent leakage in one of the needle set lines, so it was also replaced.Pt's mother wanted to know if her daughter lost a lot of drug this way, from description of what happened, it was determined that the amount of fluid is not significant.No side effect reported.Unknown date of event.Unknown if prescriber is aware.Unknown if patient missed a dose.Unknown if patient has defective product on hand for return.Indication: common variable immunodeficiency, unspecified.Reported to (b)(6) by: patient/caregiver.Reference report: mw5117169.

• Brand Name: INF SET QUICK SET23" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 16853259
• MDR Text Key: 314492082
• Report Number: MW5117168
• 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: 04/19/2023

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 Expiration Date: 03/21/2024
• Device Model Number: MMT-392
• Device Lot Number: 5404440
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2023
• Patient Sequence Number: 1
• Patient Sex: Female