MAUDE Adverse Event Report: RADIOMETER MEDICAL APS PICO70

Model Number	956-522
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should be "no information".
Event or Problem Description
According to the complaint, at (b)(6) a user collected blood with a pico70 for a blood gas analysis.In the process of collecting arterial blood, the needle hurt the user's finger when the tip of the needle was inserted into the rubber.When the user's finger was stabbed, the wound was immediately disinfected and bandaged.
Additional Manufacturer Narrative
This incident is considered a use error as the nurse accidentally pricked her own finger during penetration of the rubber cube.Further, it also been stated by the customer that there was no product quality issues.

• Brand Name: PICO70
• Common Device Name: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 9408424
• Report Number: 3002807968-2019-00059
• Device Sequence Number: 2929850
• Product Code: JKA
• UDI-Device Identifier: 05700699565228
• UDI-Public: (01)05700699565228(17)201023(10)BX57
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 10/23/2020
• Device Model Number: 956-522
• Device Catalogue Number: 956-522
• Device Lot Number: BX57
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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