MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-623
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 9217757
• Report Number: 3002807968-2019-00050
• Device Sequence Number: 16732291
• Product Code: JKA
• UDI-Device Identifier: 05700699566232
• UDI-Public: (01)05700699566232(17)210419(10)HJ52
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 04/17/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 10/23/2019; 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other