MAUDE Adverse Event Report: NEXUS MEDICAL, LLC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number PTB6824N-!W2R

Device Problems Backflow (1064); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Insufficient Information (4580)

Event Date 05/13/2022

Event Type  malfunction  

Event Description

This rn flushed and connected medication tubing to proximal lumen of patient's picc line then began running.36ml/2minutes on pump.After the 2 minutes was complete, this rn noted back flow of blood in the picc and blood leaking onto patient's bedding.Proximal lumen clamped and hole found to be near the red clamp on the quad fusion set.New line prepared and connect.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• MDR Report Key: 15102901
• MDR Text Key: 296584494
• Report Number: 15102901
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PTB6824N-!W2R
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1