MAUDE Adverse Event Report: RADIOMETER MEDICAL APS PICO70

Model Number	956-534
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information/unknown.No information.
Event or Problem Description
According to the complaint a needle stick incident occurred in july.When the nurse used the sampler, she did not follow the proper handling procedure, when she re-capped after sampling.Then she sticked her finger by herself.She wore gloves and the blood was not specific hazard full.As a result, there was no infect.
Additional Manufacturer Narrative
Investigation of the event has concluded that the needle stick incident happened because of use error by the operator.Users at the customer site were retrained in dept, incl.The nurse who got stung, about the proper handling and other sampler with safeguard device were introduced.

• Brand Name: PICO70
• Common Device Name: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 10389583
• Report Number: 3002807968-2020-00033
• Device Sequence Number: 2814011
• Product Code: JKA
• UDI-Device Identifier: 05700699565341
• UDI-Public: 05700699565341
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 02/18/2022
• Device Model Number: 956-534
• Device Catalogue Number: 956-534
• Device Lot Number: IJ50
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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