MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO WITHOUT NEEDLE

Model Number	956-610
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is stated that the device is not available for evaluation.Radiometer has asked the customer to return the affected sampler, but have not received any answer yet.
Event or Problem Description
The (b)(6) 2020, the nurse has been exposed to blood because of a safepico syringe default.Just after drawing an arterial sample, she tried to purge it and blood leaked by the piston which caused a blood spillage.It was reported that the blood sprayed on the clothes of the nurse.No blood came into contact with the skin or mucous membranes of the nurse, she was wearing a blouse and protective glasses.The customer reported this incident to the local authorities (ansm).
Additional Manufacturer Narrative
In the finalized investigation the documentation has been checked.No reports in production journals related to reported issue.Reference samples taken from storage has been checked in pressure test.No leakage observed during the test.All samples are fully functional.The defective sampler from the customer was not returned.As the defective sampler was not delivered and all reference samples are fully functional- the root cause cannot be identified and remains as unknown.

• Brand Name: SAFEPICO WITHOUT NEEDLE
• Common Device Name: SAFEPICO WITHOUT NEEDLE
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 11235854
• Report Number: 3002807968-2021-00003
• Device Sequence Number: 4371704
• Product Code: JKA
• UDI-Device Identifier: 05700699566102
• UDI-Public: (01)05700699566102(17)220624(10)IU05
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 956-610
• Device Catalogue Number: 956-610
• Device Lot Number: IU-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1