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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, a nurse didn't succeed to activate the needle shield device on a safepico on thursday the 13th (b)(6).At the end of the arterial sampling, the retraction device of the gasometry syringe did not work, forcing the customer to leave the needle unsafe for the time to proceed with the compression of the puncture point and then to manipulate the syringe to manually withdraw the collection system.The event occurred several times in the same day (3 times) but had already occurred the previous days (same batch).
Event or Problem Description
According to the complaint, a nurse didn't succeed to activate the needle shield device on a safepico on thursday the (b)(6).At the end of the arterial sampling, the retraction device of the gasometry syringe did not work, forcing the customer to leave the needle unsafe for the time to proceed with the compression of the puncture point and then to manipulate the syringe to manually withdraw the collection system.The event occurred several times in the same day (3 times) but had already occurred the previous days (same batch).According to information received from customer january 31, 2022, the same issue appeared again on the same batch number.
Additional Manufacturer Narrative
Reference samples were checked and all were within specification.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; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13384165
• Report Number: 3002807968-2022-00003
• Device Sequence Number: 5136240
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)231102(10)ME50
• 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): 02/28/2022

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: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: ME-50
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/28/2022
• 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