MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® LINE DRAW ARTERIAL BLOOD SAMPLING KIT; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number G1469J

Device Problem Bent (1059)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the event occurred in (b)(6) 2017.The exact date is unknown.

Event Description

It was reported that the syringe tip of a portex® line draw arterial blood sampling kit bent, causing an exposure of blood.The device had been used to collect blood through an artery line, and the user was connecting a syringe and attempting to perform a deflation at the time of the event.No injury to patient or clinician was reported.

Manufacturer Narrative

Two unused and one used needle-pro® arterial blood gas line draw kits were returned for investigation.The device history record was reviewed and no discrepancies or anomalies were found.A visual inspection found the used device to have the luer broken off and the tip remaining inside the filter pro.The unused samples were tested with a simulated use test, and both samples passed.A root cause related to manufacturing could not be determined.A proposed root cause was a use error involving stress upon the device applied by the user.The complaint was confirmed.

• Brand Name: PORTEX® LINE DRAW ARTERIAL BLOOD SAMPLING KIT
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: 6778402
• MDR Text Key: 82496702
• Report Number: 3012307300-2017-01834
• Device Sequence Number: 0
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: G1469J
• Device Lot Number: 3378646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1