MAUDE Adverse Event Report: AprioMed AB Bonopty Penetration Set 12G, 10 cm

Catalog Number	12-1272
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury

• Brand Name: Bonopty Penetration Set 12G, 10 cm
• Common Device Name: Bonopty Penetration Set
• Manufacturer (Section D): AprioMed AB; virdings allé 28; uppsala, SE- 7 54 5; SW SE- 754 50
• Manufacturer (Section G): Cenova AB; florettgatan 4; mjölby, SE-59 5 43; SW SE-595 43
• Manufacturer Contact: katrin svensson ; virdings allé 28; uppsala, SE- 7-54 5 ; SW SE- 754 50
• MDR Report Key: 50853231
• Report Number: 3007664053-2026-00004
• Device Sequence Number: 10025848
• Product Code: GAA
• UDI-Device Identifier: 07350031350302
• UDI-Public: 07350031350302
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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 Catalogue Number: 12-1272
• Device Lot Number: 2412080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Male