MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-613
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Radiometer complaint reference: (b)(4).According to the complaint, on (b)(6) 2025 a customer was opening the packaging of the safepico sampler (lot number: df11) and was pricked by the needle, as it was missing the needle protective cover.The sampler was an unused sampler when the incident occurred.This issue is covered by risk id 74 with a severity of 4 (permanent/serious) according to the (b)(4) - product risk analysis for samplers, (rev.21).No reports of death.
Additional Manufacturer Narrative
The defective product was not returned to radiometer for investigation.Radiometer investigations of the production record had identified the root cause to be a raw material issue.

• 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 22724979
• Report Number: 3002807968-2025-00105
• Device Sequence Number: 8288408
• Product Code: JKA
• UDI-Device Identifier: 05700699566133
• UDI-Public: (01)05700699566133(17)261212(10)DF11
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: 956-613
• Device Catalogue Number: 956-613
• Device Lot Number: DF11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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: Other
• Patient Sex: Unknown