MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO ASPIRATOR

Model Number	956-615
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Radiometer complaint reference: (b)(4).According to the complaint, on (b)(6) 2026 while using the safepico sampler (lot number: ee52), the user was contaminated with blood from the sampler.There was a crack in the lower part of the sampler.

• Brand Name: SAFEPICO ASPIRATOR
• Common Device Name: SAFEPICO ASPIRATOR
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 24066111
• Report Number: 3002807968-2026-00006
• Device Sequence Number: 10282726
• Product Code: JKA
• UDI-Device Identifier: 05700699566157
• UDI-Public: (01)05700699566157(17)271028(10)EE52
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 956-615
• Device Catalogue Number: 956-615
• Device Lot Number: EE52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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: Other
• Patient Sex: Unknown