MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-614
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated based on date of awareness.No date was provided in the complaint.
Event or Problem Description
According to the complaint, on an unknown date, a used needle was thrown into the garbage bag without using the safeguard.When a nurse then tried to throw the garbage bag away, she was pricked by the used needle.According to the hospital's rules, safeguards shall be used and thrown into the special plastic trash can.This case is therefore considered a user error.
Additional Manufacturer Narrative
The cause of the reported problem could not be investigated due to lack of product data.Furthermore, the case have been reported as an use error.

• Brand Name: SAFEPICO
• Common Device Name: SAFEPICO
• 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: pearlyn pah ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 15173663
• Report Number: 3002807968-2022-00027
• Device Sequence Number: 5072674
• Product Code: JKA
• UDI-Device Identifier: 05700699566140
• UDI-Public: (01)05700699566140
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 956-614
• Device Catalogue Number: 956-614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown