MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-616

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  Injury  

Event Description

On the (b)(6) 2022 early in the morning there was an accident on the medicine ward where one in the staff injured herself with a needle from a syringe.Articel code safepico 956-616.Lot:nr mr-03.The needle shield was moved forward by the nurse to protect the needle but it was not locked in the endposition.When the nurse should remove the needle including the shield from the syringe the needleshield moved back again and she was injured by the needle in her fingertip.

Manufacturer Narrative

The radiometer investigation has concluded that the root cause of this nonconformity is user error.The defective device was discarded by the customer.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: ditte kroeyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 14769668
• MDR Text Key: 294507108
• Report Number: 3002807968-2022-00023
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)240308(10)MR03
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K043143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other