MAUDE Adverse Event Report: HU-FRIEDY MANUFACTURING CO., LLC STREAMLINE PLUS #1000 INSERT, 30K

Model Number	UI30SP1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device subject of the reported event was returned to hu-friedy for evaluation.Evaluation found that the breakage may be due to dropped, or misused insert.The reprocessing of hu-friedy dental hand instruments and accessories states "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not use damaged instruments." the device history record for the subject lot was reviewed and no abnormalities were noted.
Event or Problem Description
During a dental procedure, the instrument's tip broke in the patient's mouth.The patient swallowed the tip and was sent to the hospital to have it removed with surgery.

• Brand Name: STREAMLINE PLUS #1000 INSERT, 30K
• Common Device Name: STREAMLINE PLUS #1000 INSERT, 30K
• Manufacturer (Section D): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MANUFACTURING CO., LLC; 3232 n. rockwell st; chicago IL 60618
• Manufacturer Contact: stephanie wasielewski ; 3232 n. rockwell st; chicago, IL 60618
• MDR Report Key: 22437445
• Report Number: 1416605-2025-00006
• Device Sequence Number: 3151491
• Product Code: ELC
• UDI-Device Identifier: 10889950121099
• UDI-Public: (01)10889950121099
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UI30SP1000
• Device Catalogue Number: UI30SP1000
• Device Lot Number: 06/23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown