MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-LINER, SOFT, KIT,1500CC,SOLIDIFIER P

Catalog Number OR1920PG

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hypoxia (1918)

Event Date 02/19/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, the suction failed to function causing an "accumulation of secretions" and "hypoxia".The customer reported the patient "had to be resuscitated".The customer reported the lids do not seal appropriately and suction is lost.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, the suction failed to function causing an "accumulation of secretions" and "hypoxia".

Manufacturer Narrative

Update d9: returned to manufacturer.Update h3: device evaluated by manufacturer.Update h6: type of investigation.

• Type of Device: DBD-LINER, SOFT, KIT,1500CC,SOLIDIFIER P
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18012440
• MDR Text Key: 326625986
• Report Number: 1417592-2023-00426
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OR1920PG
• Device Lot Number: 670220805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other