MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number 956-614

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2017

Event Type  Injury  

Event Description

After sampling blood, the doctor slided the safeguard and put it into his white coat pocket.When he picked it up from the pocket, he pricked himself.

Manufacturer Narrative

Information from production investigation (b)(4): checking production documentation.No abnormalities in production journal related to reported issue checking reference samples.No defects found.Twenty (20) collected reference samples activated during mechanical test - no issues with opening safeguard(needle shield device) also no issue while locking the safeguard.Root cause: the batch production journals have no reports related to the issue.Also no issue with locking the safeguard noticed during the mechanical test of 20 reference samples.As defective sample was not delivered we evaluate this case as misuse of safepico product.Preventive action: training for final user suggested.Based on this information radiometer considers this case closed.

• Brand Name: SAFEPICO70
• Type of Device: SAFEPICO70
• 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: kristina toft ; åkandevej 21; brønshøj, 2700 ; DA 2700 ; 538273349
• MDR Report Key: 6586979
• MDR Text Key: 75817380
• Report Number: 3002807968-2017-00012
• Device Sequence Number: 0
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 956-614
• Device Catalogue Number: 956-614
• Device Lot Number: XV51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other