MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70; SAFEPICO70, PRODUCT CODE: JKA

Model Number	956-610
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint on (b)(6) 2018, a customer experienced a blood leakage from a crack in the syringe when they tried to remove air from the sample.Nobody came into contact with blood.According to the complaint on (b)(6) 2018, a customer experienced a blood leakage from a crack in the syringe when they tried to remove air from the sample.Nobody came into contact with blood.
Additional Manufacturer Narrative
Investigation has identified that the root cause is a manufacturing error related to the labeling assembly in the production.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70, PRODUCT CODE: JKA
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00,; DA DK-2700,
• MDR Report Key: 7356609
• Report Number: 3002807968-2018-00017
• Device Sequence Number: 19267841
• Product Code: JKA
• UDI-Device Identifier: 05700699566102
• UDI-Public: (01)05700699566102(17)191028(10)YV56
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 956-610
• Device Catalogue Number: 956-610
• Device Lot Number: YV-56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1