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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PL; BIVONA TTS

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SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PL; BIVONA TTS Back to Search Results
Device Problem Optical Discoloration (2999)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Two (2) samples were received in used conditions, without their certificate of decontamination and without their original packaging inside a ziploc bag.Visual inspection was performed at 12 under normal lighting to received unit, in order to detect any damage on the cuff or airline.It was observed that the units have a blue condition on the pilot balloon, connector and tube.The complaint is confirmed.Functional test was performed where samples were filled with water to see if they turn blue.The samples did not turn blue after filling with water.They remained in the blue condition as received.By other side, after the water was removed from cuff, the water was clean.It is concluded that blue condition reported by the customer is a blue foreign substance since it is not adhered to samples material.Therefore, based on visual inspection and reviewing of manufacturing process where no sources of blue contamination were found, the most probable root cause is that damaged occurred after product left shm facilities.No corrective actions were taken.No lot number was provided; therefore, device history record (dhr) review could not be completed.Product information and pma/510(k) are unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that the pilot balloon component of the bivona tracheostomy turned a blue color when water was used to inflate the cuff.The issue reversed once the water was removed.No patient injury was reported.
 
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Brand Name
BIVONA UNCUFFED NEONATAL AND PEDIATRIC FLEXTEND PL
Type of Device
BIVONA TTS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
5700 west 23rd ave
gary IN 46406
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15468944
MDR Text Key305522295
Report Number3012307300-2022-20173
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/10/2022
Initial Date FDA Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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