MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-616

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Fail-Safe Problem (2936)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  malfunction  

Event Description

According to the complaint the nurse didn't succeed to activate the needle shield device on a safepico ref (b)(4) lot number hy-53 on tuesday the 27 april.No consequences on a patient but the nurse explain that there is a high risk of blood exposure because of this.No pictures or defective part available.No reports of death or serious injury.

Manufacturer Narrative

The finalized radiometer investigation has concluded that the root cause of the described event is identified as manufacturing error.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12159012
• MDR Text Key: 261278757
• Report Number: 3002807968-2021-00028
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)210920(10)HY53
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: HY-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1