MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SUCTION CANISTER FMD 762; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Device Problem Collapse (1099)

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

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Red suction canister lining imploded upon itself without provocation.Canister was in use at the time and contained bodily fluids.

• Brand Name: SUCTION CANISTER FMD 762
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 11619099
• MDR Text Key: 243950270
• Report Number: 11619099
• Device Sequence Number: 1
• Product Code: GCX
• 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: 03/31/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Date Report to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1