MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY; 1000 TRIPLE SWIVEL, 30K

Model Number	UI30SS1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Breakage may be due to dropped or misused insert, no defect found.The device history record (dhr) for the subject lot was reviewed and no abnormalities were noted.
Event or Problem Description
Customer reported tip of insert broke off during patient care.The patient went to the er as a precautionary measured because they were unsure if the tip was swallowed.No injury occured/resulted.

• Brand Name: HU-FRIEDY
• Common Device Name: 1000 TRIPLE SWIVEL, 30K
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 n. rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO., LLC; 3232 n. rockwell st.; chicago IL 60618
• Manufacturer Contact: stephanie wasielewski ; 3232 n. rockwell st.; chicago, IL 60618 ; 8472574500
• MDR Report Key: 23982534
• Report Number: 1416605-2025-00015
• Device Sequence Number: 16128425
• Product Code: ELC
• UDI-Device Identifier: 10889950075781
• UDI-Public: (01)10889950075781
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: UI30SS1000
• Device Catalogue Number: UI30SS1000
• Device Lot Number: 0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown