MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-623

Device Problem Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

According to complaint one customer staff member had a minor needle stick injury two days ago.They think that the locking mechanism may have played a role, as it can occasionally be a little difficult to engage.The incident occurred shortly after the sample collection used for diagnosis.

Manufacturer Narrative

The concerned safepico sampler was discarded by the customer, so radiometer checked and investigated reference samplers.The root cause of the needle stick event is identified as assembly process error.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12201639
• MDR Text Key: 262622553
• Report Number: 3002807968-2021-00030
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K043143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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
• Device Lot Number: KC-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other