MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number DYNJAA10475

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

The anesthesia circuit adult - lf breathing bag reported to have cracked in breathing bag attachment mount.Breathing bag is one of the components in the anesthesia circuit pack.Cracks are only occurring when placed on ge avance anesthesia machines.Causes the anesthesia machine to fail the leak test.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 12252027
• MDR Text Key: 264287569
• Report Number: 12252027
• Device Sequence Number: 1
• Product Code: CAH
• 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: 07/29/2021,06/23/2021

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 Operator: No Information
• Device Model Number: DYNJAA10475
• Device Catalogue Number: DYNJAA10475
• Device Lot Number: 21DBK003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2021
• Date Report to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1