MAUDE Adverse Event Report: VYGON VYGON; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number 873.04

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

Iv medications were infusing through a manifold as is usual practice from the or.Bedside rn was not able to unscrew tubing connected to the manifold which prevented the placement of a needleless cap and curios cap.During the attempt to unscrew with tubing, the manifold port broke off.The bedside rn had to complete a partial drip change to remove the manifold from the tubing.

• Brand Name: VYGON
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): VYGON; 87 venture drive; dover NH 03820
• MDR Report Key: 14955674
• MDR Text Key: 295488025
• Report Number: 14955674
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 873.04
• Device Catalogue Number: 00087304
• Device Lot Number: 300721AH
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female