MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PRO-VENT PLUS, 3CC LL SYRINGE, 23G X 1IN NDLE, FILTER+ EDGE; BLOOD SPECIMEN COLLECTION KIT (EXCLUDES HIV TESTING)

Catalog Number	4558PG
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after having performed a blood gas analysis using a pro-vent plus, 3cc ll syringe, 23g x 1in ndle, filter+ edge, the nurse fixed the filter pro device and then slowly pushed the plunger to release the air bubbles.All of the blood came out of the syringe dirtying the nurses in the face and eyes.The staff were exposed to contaminated blood.No other information was provided to indicate any other adverse events or medical interventions.
Event or Problem Description
It was reported there was no additional injury as a result of the event.In response to the blood exposure, the event was reported to the emergency department.The result of the event was reported as ongoing.

• Brand Name: PRO-VENT PLUS, 3CC LL SYRINGE, 23G X 1IN NDLE, FILTER+ EDGE
• Common Device Name: BLOOD SPECIMEN COLLECTION KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7164042
• Report Number: 3012307300-2018-00028
• Device Sequence Number: 1951736
• Product Code: OFZ
• UDI-Device Identifier: 30351688081166
• UDI-Public: 30351688081166
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 06/07/2020
• Device Catalogue Number: 4558PG
• Device Lot Number: 3443002
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/12/2018
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Weight: 65