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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK; CONNECTOR, AIRWAY (EXTENSION)
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TELEFLEX MEDICAL HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK; CONNECTOR, AIRWAY (EXTENSION) Back to Search Results
Catalog Number 02634-01
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: "certified register nurse assistant (crna) was in the process of intubating patient for surgery when connector piece for double lumen et tube broke.".
 
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Brand Name
HUDSON SUBASSY,SHER-I-BRONCH ACCESSORY PACK
Type of Device
CONNECTOR, AIRWAY (EXTENSION)
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10719545
MDR Text Key214152435
Report Number3003898360-2020-00858
Device Sequence Number1
Product Code BZA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02634-01
Device Lot Number73J1900749
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/04/2020
Initial Date FDA Received10/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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