MAUDE Adverse Event Report: LIEBEL-FLARSHEIM 2 X 200ML SYRINGE W/60" Y-TUBING AND DUAL CHECK VA

Model Number 844023

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2020.Incident: the end user of a hospital in colombia reported a device malfunctioning during use.Specifically, the reporter stated that the contrast leaked out while being pushed through not knowing whether the device was cracked or broken.According to the reporter, the device should last the entire shift at the ct scan room without complications and they have had to replace the device in several occasions.

• Brand Name: 2 X 200ML SYRINGE W/60" Y-TUBING AND DUAL CHECK VA
• Type of Device: 2 X 200ML SYRINGE W/60" Y-TUBING AND DUAL CHECK VA
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 10794373
• MDR Text Key: 233990245
• Report Number: 1518293-2020-00036
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR