MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DELEE MUCUS TRAP WITH CONTRO-VAC AND PLUG 8F; TRAP, STERILE SPECIMEN

Model Number DYND44108

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Product Quality Problem (1506); Suction Problem (2170)

Patient Problems Airway Obstruction (1699); Bradycardia (1751); Muscle Weakness (1967); Respiratory Insufficiency (4462)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

Newborn born with no tone, resp effort, low hr.(heartrate), ppv (positive pressure ventilation) and chest compressions begun shortly after birth.Meconium stained fluid noted, attempts to use delee mucus trap unsuccessful over several attempts.Rt feels this event could have been related to a plug and the delee did not work as intended for mec above the vocal cords.This product has been noted to not stay connected to the suction tubing and is dislodged easily while in use.This is the second event that the quality of this product has been questioned.

• Brand Name: DELEE MUCUS TRAP WITH CONTRO-VAC AND PLUG 8F
• Type of Device: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 16129929
• MDR Text Key: 307014170
• Report Number: 16129929
• Device Sequence Number: 1
• Product Code: BYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2023

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 Model Number: DYND44108
• Device Catalogue Number: DYND44108
• Device Lot Number: 18322060001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Race: Black Or African American