MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; LINER,SEMI-RIGID,1500CC,100EA/CS

Catalog Number OR515

Device Problem Decrease in Suction (1146)

Patient Problem Respiratory Insufficiency (4462)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that, a patient "decompensated due to lack of suction, resulting in the patient being transferred to the icu".It was reported that the patient is thought to have been discharged from the hospital at this time.It was reported that "that there was a gap in the seal from the lid to the liner that when the pressure is released only during low intermittent wall suction it lost the seal on the device".A sample was requested to be returned for evaluation.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.Additional possible lot numbers : 93023091428c, 93023103316c.

Event Description

Lack of suction causing patient to "decompensate".

• Type of Device: LINER,SEMI-RIGID,1500CC,100EA/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18721483
• MDR Text Key: 335585150
• Report Number: 1417592-2024-00074
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: OR515
• Device Lot Number: 55823107310C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/16/2024
• 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