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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI TUBE, TRACHEAL (W/WO CONNECTOR)

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TELEFLEX INCORPORATED HUDSON RCI TUBE, TRACHEAL (W/WO CONNECTOR) Back to Search Results
Model Number IPN048873
Event Date 02/05/2019
Event Type  Death  
Event Description

Upon intubation of this patient the hub connector came apart which required the patient to be re-intubated. This happened 3 times to this specific patient however, we have other reports that the same thing has occurred across our entire organization. There are reports of cuff failure and cuff tearing as well. We have since pulled this product from our shelves. Manufacturer response for endotracheal tube, (brand not provided) (per site reporter). Had an in-person meeting with the representatives from this company to inform them of the issues that we have been having with this device. The information we received from them was that they started having issues in 2016 and changed manufacturer due to an issue with the plastic. They have since had complaints (wouldn't share how many) however, they stated that they are unable to reproduce these same issues in the lab during simulation. They stated that they are going to start a "complaint inquiry" which sounded like a first step in an investigation that could potentially lead (depending on the findings) could result in a recall.

 
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Brand NameHUDSON RCI
Type of DeviceTUBE, TRACHEAL (W/WO CONNECTOR)
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8508629
Report Number8508629
Device Sequence Number1
Product CodeBTR
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberIPN048873
Device Catalogue Number5-10115
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/28/2019
Event Location Hospital
Date Report TO Manufacturer04/12/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/12/2019 Patient Sequence Number: 1
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