MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CLEARPRO,CLOSED SXN,14FR,T-PC,ETT

Catalog Number DYNCPTP14

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Remedial action initiated: recall - r-20-089.It was reported the suction catheter that broke while in use, had to be retrieved from the patient's endotracheal tube.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 the suctioning, when the reported break occurred, what suctioning pressures the device was subjected to, or who was using the device at the time of the incident.No additional information was provided regarding the reported incident.A recall was initiated concerning the event, see recall # r-20-089.Due to the need for medical intervention and in an abundance of caution, this is an mdr reportable event.The sample was not returned for evaluation.If additional relevant information becomes available a supplemental mdr will be filed.

Event Description

It was reported the suction catheter that broke while in use, had to be retrieved from the patient's endotracheal tube.

• Type of Device: CLEARPRO,CLOSED SXN,14FR,T-PC,ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: kathy woods ; three lakes drive; northfield, il ; 9317708
• MDR Report Key: 10177170
• MDR Text Key: 198851858
• Report Number: 1417592-2020-00068
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNCPTP14
• Device Lot Number: 06919020016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2020
• 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