MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-614

Device Problems Use of Device Problem (1670); Fail-Safe Problem (2936)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

Event Type  Injury  

Event Description

According to the complaint, one of the customer's staff stung him/herself with a safepico needle.It is possible that the user did not lock the safeguard completely.He/she has not confirmed hearing the click when the safeguard locked.The customer recognizes their use error, not confirming if the safeguard was locked.Radiometer (b)(6) will perform training on the correct usage of safepico.The safeguard has been discarded already, so it cannot be checked if the safeguard lock function was normal or not.

Manufacturer Narrative

According to the description provided by the customer, the cause of this nonconformity is a user error.As the lot no.Is not provided, it is not possible to check the documentation or reference samples.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12030827
• MDR Text Key: 262633256
• Report Number: 3002807968-2021-00021
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 956-614
• Device Catalogue Number: 956-614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other