MAUDE Adverse Event Report: NULL MEDEX HIGH PRESSURE TUBING; TUBING, PRESSURE AND ACCESSORIES

Catalog Number B1681-RCZ

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that while carrying out a angiogram, and whilst injecting a large amount of contrast into the aorta the end of the high pressure line popped off.No additional information.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-06594.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: MEDEX HIGH PRESSURE TUBING
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section G): NULL
• MDR Report Key: 14141327
• MDR Text Key: 289497923
• Report Number: 3012307300-2022-06594
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: B1681-RCZ
• Device Lot Number: 4195070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1