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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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NULL BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Device Problems Material Discolored (1170); Unexpected Color (4055)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It is reported that the customer continues to run into issues with the port and pilot lines of some tts tubes turning a blue hue.When the water is removed, it is clear.This only happens after sterilization.The central sterilization department states they are not injecting anything into the cuff during the process.
 
Manufacturer Narrative
Other, other text: no product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.(h6e) no lot number was provided for performance of a device history record review.E4 and g5 are unknown.
 
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Brand Name
BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section G)
NULL
MDR Report Key13314675
MDR Text Key284186185
Report Number3012307300-2022-01338
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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