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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/17/2017

Event Type  Injury  

Event 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 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
• Type of Device: BLOOD SPECIMEN COLLECTION KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7164042
• MDR Text Key: 96360949
• Report Number: 3012307300-2018-00028
• Device Sequence Number: 1
• Product Code: OFZ
• UDI-Device Identifier: 30351688081166
• UDI-Public: 30351688081166
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2020
• Device Catalogue Number: 4558PG
• Device Lot Number: 3443002
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 65