MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-623

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/05/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the needle guard was blocked on a safepico 956-623 (lot: nl51) when the user (female, age 24) was handling it.The user took the blood sample and afterwards pricked her finger with the used needle.The user was checked and continued working after the incident.

Manufacturer Narrative

The defective sampler was not delivered and no photo was provided.Reference samples were checked and were within specification.Problems with activation of the needle shield device are known and may occur due to assembly process error.

• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 17304838
• MDR Text Key: 319014639
• Report Number: 3002807968-2023-00029
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 05700699566232
• UDI-Public: (01)05700699566232(17)250124(10)NL51
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: NL51
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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
• Patient Age: 24 YR
• Patient Sex: Female