MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; RT INTUBATION TRAY 368986-R

Model Number ACC010226F

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2022

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2022 during a 'code blue event in the icu code cart was cracked and intubation tray was opened for intubation if needed'.Upon opening the intubation tray it was noted that the code cart contained 'tracheostomy tubes and trach securement device instead of oral endotracheal and endotracheal securement devices'.

Manufacturer Narrative

According to the facility on (b)(6) 2022 during a 'code blue event in the icu code cart was cracked and intubation tray was opened for intubation if needed'.Upon opening the intubation tray it was noted that the code cart contained 'tracheostomy tubes and trach securement device instead of oral endotracheal and endotracheal securement devices'.Per the facility the respiratory therapist obtained an intubation tray with correct supplies that was outside the room.The facility reported there was no impact to the patient's outcome and they are being discharged home.The device is not available to be returned for evaluation.No additional information is available at this time.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.

• Brand Name: Medline Industries, Inc.
• Type of Device: RT INTUBATION TRAY 368986-R
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16018285
• MDR Text Key: 305871099
• Report Number: 1423395-2022-00047
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACC010226F
• Device Catalogue Number: ACC010226F
• Device Lot Number: 21JDA010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 82 KG