MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CLEARPRO,CLOSED SXN,14FR,D SWVL,TRACH

Catalog Number DYNCPDS14T

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that a catheter split in half.Manual intervention was required to remove the broken off piece.After multiple good faith attempts the reporting facility remained unable or unwilling to provide additional patient, product, or procedural information related to this report.It is unknown at what point during suctioning the reported break occurred, what suction pressures the device was subjected to, or who was using the device at the time of the incident.No impact or adverse effect to the patient was originally reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported need for medical intervention to remove the broken suction catheter piece from the patient's tracheostomy, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a catheter split in half.Manual intervention was required to remove the broken off piece.

• Type of Device: CLEARPRO,CLOSED SXN,14FR,D SWVL,TRACH
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10353826
• MDR Text Key: 202933799
• Report Number: 1417592-2020-00087
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNCPDS14T
• Device Lot Number: 6919020016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• 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): Required Intervention