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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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NULL; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number 54-05-112
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2020
Event Type  malfunction  
Event Description
It was reported that a connector was in use with a non original equipment manufacturer's (oem) endotracheal tube.The tube's pilot balloon got caught in the connection part of the extension tube and would not allow the cuff to be deflated properly.No patient injury was reported.
 
Manufacturer Narrative
The device was received to perform an investigation.A device history record (dhr) review was unable to be performed as it is held by the supplier.The device was forwarded to the supplier and a supplier non conformance notification was initiated.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
 
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Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section G)
NULL
MDR Report Key15459513
MDR Text Key306319450
Report Number3012307300-2022-19886
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number54-05-112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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