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

Catalog Number DYNJAA0349

Device Problems Break (1069); Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 12/10/2020

Event Type  malfunction  

Event Description

Multiple issues with new anesthesia circuits: a sample line connector was broken/leaked.Was identified when the anesthesia machine alarmed during use; bags have had holes in them; circuit lines with slits.

• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11130804
• MDR Text Key: 225519380
• Report Number: 11130804
• 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: 12/11/2020

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: Health Professional
• Device Catalogue Number: DYNJAA0349
• 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: 12/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1