MAUDE Adverse Event Report: SAGE PRODUCTS LLC SAGE PRIMAFIT; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

Lot Number	99514
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Female purewick tubing defective.Tubing is attached to plastic packing and pinched off mid-way through tubing, device unusable.It looks like the problem occurred on the conveyer during packaging.The timing was off, cutting the tubing.Did not reach patient.

• Brand Name: SAGE PRIMAFIT
• Common Device Name: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 3 oaks rd; cary IL 60013
• MDR Report Key: 20683084
• Report Number: 20683084
• Device Sequence Number: 17000587
• Product Code: NZU
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2024
• Report Date (Section F): 10/21/2024

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: 99514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 10/21/2024