MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-616
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, a nurse encountered difficulty in lowering the needle shield device onto the needle of the safepico (lot number: ny 54).She cut her skin (superficial wound) while trying to set up the needle shield device.She did not prick herself with the needle and there was no exposure to blood.
Additional Manufacturer Narrative
Date of event in b3 is estimated.Customer have discared the used safepico.
Additional Manufacturer Narrative
The defective product was not returned to radiometer.Radiometer investigation was not able to identified the root cause of the issue.Hence the root cause is unknown.

• Brand Name: SAFEPICO
• Common Device Name: SAFEPICO
• 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: 17928856
• Report Number: 3002807968-2023-00047
• Device Sequence Number: 6352327
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)250519(10)NY54
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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 Expiration Date: 05/19/2025
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: NY 54
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• 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