MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. BAYER HEALTH SYRINGE KIT; IV CONTRAST INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Lot Number 8591780

Device Problem Break (1069)

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

Event Date 03/22/2021

Event Type  malfunction  

Event Description

Tubing used to inject intravenous contrast broken at connection point to hub for angio catheter needle.Fda safety report id # (b)(4).

• Brand Name: BAYER HEALTH SYRINGE KIT
• Type of Device: IV CONTRAST INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.
• MDR Report Key: 11613073
• MDR Text Key: 243952263
• Report Number: MW5100534
• Device Sequence Number: 1
• Product Code: IZQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 8591780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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