MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-623

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated based on date of awareness.No date was provided in the complaint.

Event Description

According to the complaint, the nurse was not able to activate the needle shield device on the safepico and was pricked by the needle at the end of the arterial sampling.

Manufacturer Narrative

Date of awareness is now provided, to be 2022-nov-16.The safepico in this complaint is not available for investigation.But investigations is currently still ongoing.

Manufacturer Narrative

The radiometer investigation has found that the root cause was traced to manufacturing, where the glue from the barcode label melts after the sterilisation process and can stick to the needle shield device of the safepico.

• Brand Name: SAFEPICO
• Type of Device: 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: 15842065
• MDR Text Key: 304097023
• Report Number: 3002807968-2022-00039
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 05700699566232
• UDI-Public: (01)05700699566232
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 956-623
• Device Catalogue Number: 956-623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other