MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-616
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mfg report number: 3002807968-2018-00052.
Event or Problem Description
After taking the sample, the user tried to expel the air out of the syringe and it squirted blood into his mouth and on his face.Ppe (face shield) was not used.Customer stated that the side of the barrel was possibly cracked.According to the customer there was no harm to the user.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, da DK-27 00; DA DK-2700
• MDR Report Key: 7782430
• Report Number: 1523456-2018-00003
• Device Sequence Number: 1378561
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)190928(10)YT59
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2018
• Report Date (Section F): 08/14/2018

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: 09/28/2019
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: YT-59
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 75
• Date Report Sent to FDA: 08/14/2018