MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

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	05/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, blood projected out from the syringe due to a crack on the body of the syringe.The user was not in contact with blood.
Additional Manufacturer Narrative
It is stated that the device was evaluated by the manufacturer, but that the device not was returned to the manufacturer.This is because device evaluation was performed on a device from the same lot but not on the actual device.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
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7555769
• Report Number: 3002807968-2018-00039
• Device Sequence Number: 10821089
• Product Code: JKA
• UDI-Device Identifier: 05700699566102
• UDI-Public: (01)05700699566102(17)200311(10)BE54
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: 03/11/2020
• Device Model Number: 956-610
• Device Catalogue Number: 956-610
• Device Lot Number: BE-54
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1