MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-623

Device Problem 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

Manufacturers report number: 3002808968-2019-00050.The affected device is not available and has not been returned to radiometer.The date of event stated is best approximation.

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.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• MDR Report Key: 9217951
• MDR Text Key: 169732548
• Report Number: 1523456-2019-00004
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2019
• Distributor Facility Aware Date: 10/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other