MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-613
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radiometer reference number: (b)(4).According to complaint, the customer reported that on 04nov2025, when the nurse opened the packaging of a safepico70 (lot number cj05) to collect an arterial blood sample, she found that the needle was rusty.She immediately reported it to the head nurse and did not use the sampler.A new safepico was used to collect the sample from the patient.No harm was caused to the patient.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70
• 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: anette gram ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23581489
• Report Number: 3002807968-2025-00135
• Device Sequence Number: 9305475
• Product Code: JKA
• UDI-Device Identifier: 05700699566133
• UDI-Public: (01)05700699566133(17)260708(10)CJ05
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/15/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2026
• Device Model Number: 956-613
• Device Catalogue Number: 956-613
• Device Lot Number: CJ05
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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
• Patient Sex: Unknown