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

Model Number DYNJAA10429

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  malfunction  

Event Description

Broken medline anesthesia circuit-lf kit.Manufacturer response for anesthesia adult circuit kit, medline (per site reporter).Request for the device to be sent back for evaluation.

• Brand Name: ANESTHESIA ADULT CIRCUIT-LF
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13666176
• MDR Text Key: 286588611
• Report Number: 13666176
• 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: 03/02/2022,12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJAA10429
• Device Catalogue Number: DYNJAA10429
• Device Lot Number: 21FBL693
• 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: 03/02/2022
• Date Report to Manufacturer: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1