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

Lot Number 21DBR593, 21CBG178

Device Problems Break (1069); Crack (1135); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Breathing bag in anesthesia circuit with plastic cracking at the attachment causing a break in seal.Report by tech is this is happening in about 40% of the anesthesia circuits (medline).Circuits not passing on morning checks and breathing bag with crack needing to be replaced.

• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 12487563
• MDR Text Key: 271899021
• Report Number: 12487563
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2021,06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 21DBR593, 21CBG178
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2021
• Date Report to Manufacturer: 09/17/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1