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

Model Number	956-622
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number and therefore also udi is unknown but it is either: lot mr14 : udi =(b)(4) or lot mr15 : udi = (b)(4).
Event or Problem Description
According to the complaint, on (b)(6) 2022, when the operator tried to ventilate air from the sampler, the tip cap (vtc) got out of the sampler, and the blood inside the sampler spurted up to the ceiling.According to a radiometer service engineer who visited the hospital, the operator was trained, and this event occurred when the operator tried to ventilate air as usual (with the same force as usual).No one was exposed to the blood.
Additional Manufacturer Narrative
Due to no defects in defective sample was found, all reference samples within specification and no deviations in production documentation has been found - root cause cannot be identified.Lot number corrected to mr-19.

• 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; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: christoffer thaysen ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 15518596
• Report Number: 3002807968-2022-00032
• Device Sequence Number: 2690307
• Product Code: JKA
• UDI-Device Identifier: 05700699566225
• UDI-Public: (01)05700699566225(17)240317(10)MR19
• 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): 11/16/2022

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: 956-622
• Device Catalogue Number: 956-622
• Device Lot Number: MR19
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/19/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/16/2022
• 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