MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-623
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated based on date of awareness.No date was provided in the complaint.
Event or Problem Description
According to the complaint, the nurse was not able to activate the needle shield device on the safepico and was pricked by the needle at the end of the arterial sampling.
Additional Manufacturer Narrative
Date of awareness is now provided, to be 2022-nov-16.The safepico in this complaint is not available for investigation.But investigations is currently still ongoing.
Additional Manufacturer Narrative
The radiometer investigation has found that the root cause was traced to manufacturing, where the glue from the barcode label melts after the sterilisation process and can stick to the needle shield device of the safepico.

• 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: pearlyn pah ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 15842065
• Report Number: 3002807968-2022-00039
• Device Sequence Number: 17603865
• Product Code: JKA
• UDI-Device Identifier: 05700699566232
• UDI-Public: (01)05700699566232
• 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,Followup
• Report Date (Section B): 01/04/2023

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: 956-623
• Device Catalogue Number: 956-623
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 12/22/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/20/2022; 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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