MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; KIT,CATHETER,SUCTION,14 FR,WHISTL,2 GLV

Catalog Number DYND40972

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that with an unknown number of patients, when extracting the tube, the green attachment at end of the tube would just fall off requiring the catheter to be pulled out of the trach.The facility stated that they were able to manually retrieve the entire tube, put the device to the side, get another catheter and complete the patient's procedures without further incident.There was no report of any adverse patient consequence and no effect on the patient's stability, as a result of the incident.There were no signs of mishandling or product/packaging damage noted prior to use.There was no inadvertent force applied to or against the catheter during use.There was no impact to the patient's stability or oxygen level as a result of the incident.There was no serious injury identified or follow up care required related to the event.The catheter was replaced and the procedure was completed as planned.There were no complications noted with any patient during or after the procedure.One of the actual devices was returned to the manufacturer for evaluation, however the evaluation in still in process.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.

Event Description

When extracting the suction catheter, from an unknown number of patients, the green attachment on the suction catheter disconnected from the tubing requiring the tubing to be manually removed from the patient trach tube.

• Type of Device: KIT,CATHETER,SUCTION,14 FR,WHISTL,2 GLV
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10575521
• MDR Text Key: 208718306
• Report Number: 1417592-2020-00103
• Device Sequence Number: 1
• Product Code: OFR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND40972
• Device Lot Number: 6052004012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention