MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-623

Device Problems Detachment of Device or Device Component (2907); Fail-Safe Did Not Operate (4046)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

The affected device is not available and has not been returned to radiometer.The date of event stated is best approximation.Importers report number: (b)(4).

Event Description

A respiratory therapist had a needle stick from safepico blood sampler.After normal blood sampling procedure the therapist could not activate the safety shield of the sampler, which ultimately led to a finger stick.The therapist stated that she has experienced several blood samplers where this safety mechanisms fails to work.The therapist was following tested in the emergency department after the needle stick.

Manufacturer Narrative

In this follow-up report #1 the patient code(s) and device code(s) has been updated in field h6 to reflect the codes used in the associated initial importers report.

Manufacturer Narrative

The defective sampler was not returned to radiometer and could therefore not be examined.Reference samples were checked under visual inspection.The checked samples were all in specification with no issues observed.Additionally mechanical test were performed.There were no problems with safeguard opening observed.All the tested samples were with proper functionality.Since the defective sampler was not returned and no issues in reference samples were observed, the root cause could not be identified.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 9217757
• MDR Text Key: 176338446
• Report Number: 3002807968-2019-00050
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 05700699566232
• UDI-Public: (01)05700699566232(17)210419(10)HJ52
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

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 Expiration Date: 04/19/2021
• Device Model Number: 956-623
• Device Catalogue Number: 956-623
• Device Lot Number: HJ52
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 10/22/2019; 04/17/2020
• Supplement Dates FDA Received: 10/23/2019; 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other