MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-614
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complaint a customer staff stung him/herself with safepico needle.According to the sales representative, it seems that the customer has not locked the safeguard completely.The case is clearly a user error.
Additional Manufacturer Narrative
Date of event is estimated based on date of awareness.According to the complaint this event occurred on end of (b)(6) 2021.No further information.
Additional Manufacturer Narrative
The cause of the reported problem could not be investigated due to lack of product data."unfortunately lot# is unknown and the customer has already discarded this sampler & safeguard.

• 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: ditte krøyer ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 14314509
• Report Number: 3002807968-2022-00014
• Device Sequence Number: 5376927
• 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): 06/13/2022

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: 04/25/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown