MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PRIMARY ADULT INTUBATION KIT

Catalog Number DYNJAA247

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient was undergoing an unspecified procedure and the endotracheal tube (ett) was noted to be twisted inside of the patient resulting in the inability to ventilate the patient.The facility reported that the incident occurred during the procedure and the patient had to be intubated again.No additional information is available at this time.There was no further intervention reported related to the incident.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has not been returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the endotracheal tube was kinked inside of the patient and the endotracheal tube was required to be reinserted.

• Type of Device: PRIMARY ADULT INTUBATION KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, il ; 6434960
• MDR Report Key: 9857885
• MDR Text Key: 190761575
• Report Number: 1417592-2020-00029
• Device Sequence Number: 1
• Product Code: CAI
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJAA247
• Device Lot Number: 19182386
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention