MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-616
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is best guess.
Event or Problem Description
According to the complaint, blood sprayed uncontrollably out from the syringe.The user (a nurse) was not in contact with blood.
Additional Manufacturer Narrative
Investigation has identified that the root cause is a manufacturing error related to the labelling assembly in the production.
Additional Manufacturer Narrative
Besides the fact that the investigation has identified that the root cause is a manufacturing error related to the labelling assembly in the production, the implemented production changes are: extension of 100% visual inspection to cover all products on the affected production line.Changes on the labeling station: rotation angle: rotation of cylinder during labelling process.Velocity: speed of cylinder's rotation during labelling process.Dispenser speed: speed of feeding label during labelling process.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7497783
• Report Number: 3002807968-2018-00034
• Device Sequence Number: 1717969
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)191021(10)YV55
• 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,Followup
• Report Date (Section B): 07/12/2018

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: Nurse
• Device Expiration Date: 10/21/2019
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: YV-55
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 05/17/2018; 06/18/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/12/2018; 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1