MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-616
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint blood leaked from the sampler due to a crack in the sampler.The operator used gloves, but blood splashed to the skin.The skin was cleaned immediately.According to the customer, the blood sample had no infectious disease.
Additional Manufacturer Narrative
Root cause production documentation have been checked - no record of crack detected during inspection was found and no records related to the issue within assembly process were recorded; all process parameters were within expected limits.Reference samples have been checked - no cylinder crack detected during the check.Defective sample evaluated by photo the defect is visible.During the investigation, it was confirmed that cracks on the cylinder occurred during or after samplers' assembly process.The blood leakage was caused by defect in syringe's cylinder.The direct root cause of reported issue could not be established within this investigation.Preventive actions all operators were informed to pay closer attention during products inspection.As the direct root cause of the issue is not yet known, other preventive actions were not implemented.
Additional Manufacturer Narrative
Investigation has identified that the root cause is a manufacturing error related to the labelling 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: 7181521
• Report Number: 3002807968-2018-00005
• Device Sequence Number: 11020000
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)190511(10)YM51
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2018

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: 05/11/2019
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: YM51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 02/22/2018; 05/17/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/09/2018; 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1