MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-615
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the nurse failed to activate the nsd (needle shield device) on a safepico.It was later confirmed that no one was injured/pricked with the needle.
Additional Manufacturer Narrative
Date of incident is estimated from date of awareness.
Additional Manufacturer Narrative
Problems with activation of the needle shield device are known and may occur due to assembly process error.

• Brand Name: SAFEPICO
• Common Device Name: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: cecilie jensen ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 16278819
• Report Number: 3002807968-2023-00002
• Device Sequence Number: 12510731
• Product Code: JKA
• UDI-Device Identifier: 05700699566157
• UDI-Public: (01)05700699566157(17)240225(10)MQ52
• 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): 03/16/2023

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 Model Number: 956-615
• Device Catalogue Number: 956-615
• Device Lot Number: MQ-52
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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