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	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stated date of the event is best guess.
Event or Problem Description
According to the complaint received, the customer reported that blood leaked out of a crack on the side of the syringe when the blood sample was ventilated.The user was hit in the eye with (b)(6) infected blood.
Additional Manufacturer Narrative
All available reference samples were checked and no syringe cracks were detected.No other defects were found.Production documentation showed that all process parameters were within expected limits.Reference samples were checked under the visual inspection - no defects detected.No syringe crack detected.All samples meet the requirements.The direct root cause of reported issue cannot be established within this investigation.The root cause will be investigated further in a capa (b)(4).
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
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• MDR Report Key: 7364955
• Report Number: 3002807968-2018-00019
• Device Sequence Number: 1235870
• Product Code: JKA
• UDI-Device Identifier: 05700699566102
• UDI-Public: (01)05700699566102(17)200214(10)BD52
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: 956-610
• Device Catalogue Number: 956-610
• Device Lot Number: BD-52
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 04/26/2018; 05/17/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 05/25/2018; 06/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other