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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC

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SMITHS MEDICAL ASD, INC. BIVONA; BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC Back to Search Results
Model Number 67PFSS35
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
A product sample was received for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that multiple bivona trachs failed to inflate during pre-test.Multiple lots affected with 11 trachs in total.No patient injury reported.
 
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Brand Name
BIVONA
Type of Device
BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
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 Key15461810
MDR Text Key306011504
Report Number3012307300-2022-19947
Device Sequence Number1
Product Code BTO
UDI-Device Identifier10351688518682
UDI-Public10351688518682
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K923878
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/21/2022
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
Device Model Number67PFSS35
Device Catalogue Number67PFSS35
Device Lot Number3894917
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/10/2022
Initial Date FDA Received09/21/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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