MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING DEVICE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 4646E

Device Problem Break (1069)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/26/2014

Event Type  Injury  

Event Description

User facility reported that the device was in use for blood draw with pt.According to reporter, the needle was removed and filter device was attached to syringe in order to expel air from the blood sample.During this process, reporter stated the filter syringe tip broke off allegedly causing the pt's blood to expel from the device and splash the clinician in the face.Clinician was given blood exposure treatment (pt hepatitis positive).Further info has been requested; no permanent adverse effects to clinician reported.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated, the mfr will file a follow-up report detailing the results of the eval.

• Brand Name: PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING DEVICE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4372953
• MDR Text Key: 5264854
• Report Number: 2183502-2014-01000
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2017
• Device Catalogue Number: 4646E
• Device Lot Number: 2768571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2014
• Distributor Facility Aware Date: 11/26/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention