MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO ASPIRATOR

Model Number	956-622
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint when the customer was to aspirate a blood sample from a catheter, they experienced that there was hardly any stopper for the plunger of the aspirator, which caused the user to pull out the plunger of the sampler which splashed them with blood all over.No reports of death or serious injury.
Additional Manufacturer Narrative
Data logs were collected for further investigation.
Additional Manufacturer Narrative
Due to defective sample not delivered, photo of defective sample not provided and delivered unused reference samplers were fully functional - root cause cannot be identified.

• Brand Name: SAFEPICO ASPIRATOR
• Common Device Name: SAFEPICO ASPIRATOR
• 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: christoffer thaysen ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 14468831
• Report Number: 3002807968-2022-00018
• Device Sequence Number: 4685908
• Product Code: JKA
• UDI-Device Identifier: 05700699566225
• UDI-Public: (01)05700699566225(17)240215(10)MQ18
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 07/08/2022

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
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 05/24/2022; 06/23/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/22/2022; 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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