MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PRESSURE MONITORING: MEDEX TRANSTAR KIDS KITS; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Model Number MX9544

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2019

Event Type  Injury  

Event Description

Closed arterial sampling where there is a "rubber" needle-less access port.Needle-less access device was used, sample acquired and when nurse went to remove access device, the entire "rubber" port came out of the closed system.This is a product failure, not provider practice issue.We have lodged formal complaints through medwatch and the manufacturer for issues with this access port back in december of 2018.Fda safety report id # (b)(4).

• Brand Name: PRESSURE MONITORING: MEDEX TRANSTAR KIDS KITS
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8772343
• MDR Text Key: 150612017
• Report Number: MW5087944
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX9544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 1