MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO ASPIRATOR ARTERIAL BLOOD SAMPLER

Model Number	956-622
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, on b)(6) 2023, when the operator tried to vent air from blood sample in the safepico aspirator using vtc, he felt the plunger was stiff, but pushed the plunger anyway.Then blood spouted from the tip of the vtc, and the operator was exposed to the blood on his face.The operator underwent a blood test, and fortunately no infection has been confirmed at this time.It was confirmed that the operator was exposed to the blood on only his skin and clothes, not on mucous membranes such as eyes and mouth.
Additional Manufacturer Narrative
During investigation it was found that the device was either: lot nq25 - (b)(4), date of manufacturer = 27feb2023 or lot nq26 - (b)(4), date of manufacturer = 28feb2023 radiometer investigations have determined the root cause to be unknown.All reference samples from both probable lot numbers were found to meet the specifications.

• Brand Name: SAFEPICO ASPIRATOR ARTERIAL BLOOD SAMPLER
• Common Device Name: SAFEPICO ASPIRATOR ARTERIAL BLOOD SAMPLER
• 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: christoffer thaysen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 17555913
• Report Number: 3002807968-2023-00034
• Device Sequence Number: 11672437
• Product Code: JKA
• UDI-Device Identifier: 05700699566225
• UDI-Public: (01)05700699566225(17)250227(10)NQ25
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/06/2023

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: 956-622
• Device Catalogue Number: 956-622
• Device Lot Number: NQ25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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