MAUDE Adverse Event Report: TANDEM DIABETES CARE / UNOMEDICAL A/S AUTOSOFT XC INF SET GRAY 10'S - 32" 6MM; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 5408271

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  malfunction  

Event Description

#3 infusion sets defective - cannula bent.

• Brand Name: AUTOSOFT XC INF SET GRAY 10'S - 32" 6MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TANDEM DIABETES CARE / UNOMEDICAL A/S
• MDR Report Key: 17337167
• MDR Text Key: 319382325
• Report Number: MW5119520
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/11/2023

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 Lot Number: 5408271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2023
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female